You’ve spent years on the science behind your new drug. You know your product inside and out. But getting it through the FDA’s approval process is a completely different challenge. It’s like being an expert mountain climber who has all the right gear but has never seen the map for this specific peak. The IND application is that map, and it’s notoriously complex. This is precisely the role of IND submission consulting. An expert consultant is your guide—they know the route, understand the regulatory changes, and can help you sidestep common mistakes to keep your project moving forward safely and efficiently.
Key Takeaways
- Treat Expert Guidance as a Strategic Investment: The right consultant does more than prepare documents; they help you build a clear regulatory strategy, anticipate FDA questions, and avoid common pitfalls like clinical holds. This proactive approach saves significant time and resources in the long run.
- Build a Cohesive and Compelling Submission: Your IND application is a narrative that must logically connect your preclinical data, manufacturing controls, and clinical plan. Ensure every section is meticulously organized and clearly supports your product’s safety profile to make the FDA reviewer’s job straightforward.
- Drive a Proactive and Collaborative Process: A smooth submission relies on your active participation. Establish clear milestones with your consultant, leverage the pre-IND meeting for direct FDA feedback, and maintain open communication to manage timelines and address challenges before they become critical issues.
What is IND Submission Consulting?
Think of an Investigational New Drug (IND) application as your formal proposal to the FDA, asking for permission to start testing your new drug on humans. It’s a critical first step toward getting your product to market. IND submission consulting is the process of bringing in an expert to help you prepare and submit that proposal successfully. The FDA has strict requirements, and the application itself is incredibly detailed, covering everything from your drug’s chemical makeup and manufacturing process to your plans for clinical trials. A consultant acts as your guide through this complex regulatory landscape, ensuring you check every box correctly.
Getting your IND application right from the start is essential. A single mistake or omission can lead to a clinical hold, causing significant delays and adding unexpected costs to your project. A consultant doesn’t just fill out forms; they provide strategic guidance to ensure every part of your submission is thorough, compliant, and presented clearly. They help you build a compelling case for why your drug is ready for human trials, drawing on their experience with the FDA to anticipate questions and address potential concerns before they become problems. This expert support is invaluable for companies navigating the high-stakes world of drug and bioscience development, turning a daunting process into a manageable one.
What an IND Consultant Does
An IND consultant is your strategic partner for the entire submission process. Their main job is to help you prepare and submit a complete and compliant IND application. This involves much more than just paperwork. They provide critical support in designing your clinical trial protocols to meet FDA standards and help you organize all the necessary documents for market approval. This includes everything from administrative forms and summaries to detailed manufacturing information and study protocols. A good consultant also acts as your liaison with the FDA, managing communications and ensuring your submission moves forward as smoothly as possible.
Key Parts of an IND Application
A complete Investigational New Drug (IND) Application is built on three core pillars of information. First is your preclinical data from animal pharmacology and toxicology studies, which provides the rationale for testing the drug in humans. Second is the manufacturing information, which details how the drug is produced, processed, and packaged to ensure quality and consistency. The third is the clinical protocol, which outlines your plan for human trials, including study design, patient selection criteria, and safety monitoring procedures. Beyond these areas, the application includes specific documents like FDA forms (1571 and 1572), an investigator’s brochure, and a comprehensive table of contents.
Why Expert Guidance Matters
Navigating the IND submission process on your own can be risky. Simple mistakes in the application can lead to clinical holds, which halt your progress and force costly revisions. Expert guidance helps you avoid these common pitfalls. Consultants have a deep understanding of FDA regulations and know what reviewers are looking for, which allows them to identify potential issues before you even submit. They can help you manage the vast amount of data and documentation required, ensuring everything is organized and compliant. Ultimately, working with an expert can speed up your timeline to market by preventing unnecessary delays and making the entire process more efficient.
What Goes Into a Successful IND Application?
Think of your Investigational New Drug (IND) application as the complete biography of your new drug. Its purpose is to tell the FDA everything they need to know to feel confident that your product is safe enough for human testing. A successful application is thorough, well-organized, and leaves no room for questions or doubt. It’s built on four key pillars: solid preclinical data, detailed manufacturing information, a clear clinical protocol, and meticulous quality control documents. Getting each of these components right is non-negotiable. Any gaps or inconsistencies can lead to significant delays or even a clinical hold, stopping your progress in its tracks. Let’s break down what each of these critical sections involves.
Preclinical Data
Before you can test a new drug in people, you have to do your homework in the lab. The preclinical data section is where you present the results of all your animal pharmacology and toxicology studies. This is your primary evidence to the FDA that the drug is reasonably safe for initial human trials. Your application needs to show what the drug does to the body and what the body does to the drug. A lack of comprehensive data here is a major red flag for reviewers. You need to build a strong, science-backed case that justifies moving forward, and that starts with robust preclinical research.
Manufacturing Information
This part of the application, often called Chemistry, Manufacturing, and Controls (CMC), is essentially the recipe for your drug. You need to provide a detailed account of how your product is made, processed, and packaged. This includes the composition, source of ingredients, and specifications for ensuring purity and quality. The FDA needs to be certain that the product you test in your clinical trial is the same, consistent product you will produce batch after batch. This section demonstrates that you have control over your manufacturing process and can produce a stable, high-quality drug, which is fundamental to patient safety.
Clinical Protocol
Your clinical protocol is your detailed game plan for the human study. It’s a document that maps out the entire trial from start to finish. It must clearly state the objectives of the trial, the number of participants, the dosage levels, and the length of the study. It also outlines exactly how you will monitor participants and what specific outcomes you will measure to assess safety and efficacy. The protocol must be designed to protect the subjects and answer the key scientific questions about the drug. This section also includes information on the qualifications of the clinical investigators who will be conducting the study.
Quality Control Documents
This is where you prove that you have the systems in place to ensure every step of your process meets regulatory standards. Quality control documents are the backbone of your application, demonstrating compliance and attention to detail. This includes everything from your standard operating procedures (SOPs) to your data management plans. Even minor errors, like incorrect formatting or a missing document, can cause serious delays. The FDA needs to see that you have a robust quality system in place to manage your product’s lifecycle. This documentation provides the assurance that your data is reliable and that patient safety is your top priority throughout the development process.
How the IND Submission Process Works
Submitting an Investigational New Drug (IND) application is a detailed, multi-step process that requires careful planning and execution. It’s not just about filling out forms; it’s about presenting a clear, compelling case for your product’s safety and potential. Getting it right involves strategic planning, meticulous documentation, and proactive communication with the FDA. Think of it as building a strong foundation for your clinical trials. Each step is designed to ensure you meet regulatory standards and avoid delays that could set your project back. Here’s a breakdown of the key stages you’ll work through.
Plan Your Pre-IND Meeting
Before you even think about submitting your application, you should request a pre-IND meeting with the FDA. This meeting is your best opportunity to get direct feedback from the agency, clarify any questions, and align on the path forward. It’s a chance to discuss your development plan and ensure your preclinical data supports your proposed clinical trial. Skipping this step is a risk; it can lead to a clinical hold or an outright rejection of your IND. Treat this meeting as a critical part of your strategy to build a collaborative relationship with the FDA from the very beginning.
Prepare Your Documentation
Your IND application is a comprehensive story about your product. The goal is to make it as easy as possible for FDA reviewers to understand your data and your plan. Avoid common missteps like including disorganized data, dense text, or unnecessary information. Your application should be clear, concise, and well-organized. It needs to include three major areas of information: your preclinical data from animal and toxicology studies, detailed manufacturing information, and your proposed clinical protocols and investigator information. A clean, professional submission shows reviewers you’re prepared and serious about compliance.
Manage Your Timeline
Once you submit your IND, the clock starts on a 30-day review period. If the FDA doesn’t place your study on a clinical hold within that time, you can begin your trials. However, this 30-day window can become incredibly stressful if the agency issues Information Requests (IRs). Responding to IRs and revising documents under a tight deadline can stretch your team thin. The best way to manage your timeline is to get your submission right the first time. A thorough, well-prepared application minimizes the chances of receiving IRs and helps you stick to your regulatory deadline.
Communicate with the FDA
Effective communication with the FDA is essential throughout the entire IND process. It starts with the pre-IND meeting and continues through any correspondence during the review period. Your goal is to be transparent, responsive, and professional in all your interactions. Understanding the agency’s perspective and anticipating their questions can make a huge difference. Listening to experts discuss the current landscape of INDs can give you valuable insight into the best strategies for preparing a successful IND application. Clear communication builds trust and helps the review process go much more smoothly.
Common IND Challenges (and How to Solve Them)
The Investigational New Drug (IND) application process is rigorous, and it’s common for sponsors to face a few bumps along the road. From disorganized data to unexpected regulatory changes, these hurdles can cause significant delays if you’re not prepared. The key is to anticipate these challenges and have a clear strategy to address them. By understanding where others often stumble, you can take proactive steps to keep your submission on track and move closer to starting your clinical trials.
Simplify Regulatory Hurdles
One of the most effective ways to streamline your IND submission is by taking full advantage of the pre-IND meeting. This meeting is your chance to get direct feedback from the FDA before you formally submit your application. Skipping this step is a common pitfall that can lead to a clinical hold or even an outright rejection of your IND.
Think of the pre-IND meeting as a strategic alignment session. It allows you to present your development plan, ask critical questions, and understand the agency’s expectations. Preparing thoroughly for this interaction ensures you address potential agency concerns early on. An experienced consultant can help you prepare your meeting request, develop a focused briefing package, and rehearse for the meeting itself, making sure you get the clarity you need.
Organize High-Quality Data
When it comes to your IND application, how you present your data is just as important as the data itself. Reviewers at the FDA are looking for a clear, concise, and well-organized submission. Including dense text, disorganized information, or unnecessary data can make it difficult for them to assess your product’s safety profile. Your goal should be to provide a straightforward narrative that guides the reviewer through your findings and conclusions without confusion.
To solve this, focus on clarity and organization. Structure your application logically, use tables and figures to summarize complex data, and ensure every document serves a clear purpose. A well-crafted submission tells a compelling story about your product. Working with a consultant can help you refine this story, ensuring your data is presented in the most effective way to support your application.
Prevent Clinical Holds
A clinical hold is one of the most significant setbacks you can face, halting your research before it even begins. These holds are often triggered by preventable issues, such as an incomplete application, insufficient preclinical data, or concerns about patient safety. Many of these common mistakes stem from underestimating the time and resources required to assemble a comprehensive IND package.
The best way to prevent a clinical hold is through meticulous preparation. This means conducting a thorough gap analysis to identify any missing information early in the process. It also involves creating a realistic timeline and dedicating the right resources to the project. By addressing potential deficiencies before you submit, you significantly reduce the risk of the FDA putting your study on hold. A proactive, detail-oriented approach is your best defense against costly delays.
Stay on Schedule
The 30-day review period for an IND application can feel incredibly short, especially if the FDA issues Information Requests (IRs). Responding to these requests while revising documents under a tight deadline can put immense pressure on your team. Each IR adds another task to your plate, and managing multiple requests can quickly derail your timeline, forcing your team to work overtime as the deadline approaches.
Getting your IND submission right the first time is the most effective way to stay on schedule. A complete and high-quality application minimizes the chances of receiving IRs. However, it’s also wise to prepare for them. An experienced consultant can help you anticipate potential questions from the FDA and draft potential responses in advance. This preparation allows your team to respond quickly and efficiently, keeping your submission moving forward without unnecessary stress.
Adapt to New Requirements
The regulatory landscape is constantly evolving. A format or content requirement that was standard last year might be outdated today. Failing to keep up with these changes is a frequent cause of delays, as missing a single requirement can lead to the rejection of your submission. It’s not enough to know the regulations; you have to know the current regulations.
Staying informed is the only way to ensure compliance. This means continuously monitoring FDA guidance documents, attending industry workshops, and staying aware of new policies. For many teams, this is where a regulatory consultant becomes essential. A good consultant lives and breathes these updates. They make it their business to know the latest requirements, ensuring your submission is compliant with all current formatting, content, and timing rules, which helps you avoid common pitfalls and keeps your project on track.
What Affects IND Consulting Costs?
When you’re planning your budget for an Investigational New Drug (IND) application, it’s helpful to know that consulting fees aren’t one-size-fits-all. The cost can vary significantly based on your specific needs, the complexity of your product, and the scope of support you require. Think of it less like buying an off-the-shelf product and more like commissioning a custom project. The final price tag reflects the amount of time, expertise, and resources a consultant will dedicate to getting your application across the finish line with the FDA.
Understanding the key factors that influence these costs will help you have more productive conversations with potential consultants and create a realistic budget. From the nature of your product to the state of your existing data, each element plays a role in defining the project’s scope. By breaking down these components, you can better anticipate your financial needs and identify where you might need the most support. This clarity allows you to find a partner who not only fits your budget but also provides the precise expertise needed for a successful submission.
Your Product’s Complexity
The nature of your product is one of the biggest drivers of cost. A straightforward, small-molecule drug with a well-documented history will generally require less intensive consulting than a novel biologic or a gene therapy product. Complex products, like biologics, often involve more intricate manufacturing processes, extensive preclinical testing, and sophisticated clinical trial designs. This intricacy translates directly into more consulting hours for everything from strategy development to document preparation. For example, the consulting costs for biologics can range significantly, reflecting the deep involvement required for clinical trial design and regulatory submissions.
The Consultant’s Expertise
You’re not just paying for a consultant’s time; you’re investing in their experience. A highly seasoned consultant with a long track record of successful IND submissions will command a higher fee than a less experienced one. This premium is for their deep institutional knowledge and strategic insight. An expert’s familiarity with FDA requirements means they can anticipate potential agency questions, organize your submission for clarity, and guide you away from common pitfalls. While the upfront cost may be higher, this expertise can save you significant time and money in the long run by helping you avoid costly delays or deficiencies.
Pre-IND Meeting Prep
The pre-IND meeting is your first formal interaction with the FDA and a critical step in the submission process. A consultant’s role in preparing you for this meeting is a major component of their service and a key factor in the overall cost. This preparation goes far beyond just scheduling a call. It involves developing a comprehensive briefing package, defining a clear meeting strategy, and coaching your team on how to effectively communicate with regulators. Skipping or under-preparing for this meeting can lead to a clinical hold or even an outright rejection of your IND, making thorough preparation an essential investment.
Data Management Needs
An IND application is fundamentally a story told through data. The quality, completeness, and organization of your data directly impact the amount of work a consultant needs to do. If your preclinical data, manufacturing information, and clinical protocols are scattered across different formats and systems, your consultant will spend considerable time helping you consolidate and structure everything. Creating an integrative database that presents all the required evidence in a clear, cohesive manner is a foundational task. The more support you need to get your data in order, the more you can expect it to be reflected in the consulting fees.
Risk Management
A great consultant does more than just assemble your application; they help you build a strategic roadmap that anticipates and mitigates potential challenges. This proactive risk management is a core part of their value and a key cost factor. This process involves identifying potential scientific, regulatory, or clinical hurdles early on and developing a plan to address them before they become major problems. Implementing comprehensive risk management plans is an intensive, strategic exercise that requires deep expertise. This foresight helps ensure your development program stays on track and is a crucial part of a consultant’s service.
How to Choose the Right IND Consultant
Selecting an IND consultant is one of the most important decisions you’ll make on your path to FDA approval. This isn’t just about hiring someone to fill out paperwork; it’s about finding a strategic partner who will guide you through a complex and high-stakes process. The right consultant can be the difference between a smooth submission and a costly delay. To make the best choice, focus on a few key areas: their experience, communication style, support system, and the overall value they provide.
Look for Experience and Expertise
When you’re vetting consultants, experience should be at the top of your list. You want a team that has been through this process many times before. Some of the most effective consultants are former FDA employees who have reviewed these applications from the other side of the table. This kind of insider knowledge is invaluable because they know exactly what the FDA is looking for and can help you anticipate questions before they’re even asked. A consultant with deep regulatory experience can spot potential issues in your data or documentation that you might have missed, saving you from critical errors down the line.
Verify Their Industry Knowledge
FDA regulations are incredibly detailed, and a consultant’s familiarity with the specific rules governing your product is essential. Their experts should be able to guide you through the complex requirements and help prepare all the necessary paperwork with precision. Whether you’re developing a biologic, a small molecule drug, or another novel therapy, your consultant needs to understand the nuances of your field. This specialized knowledge ensures your IND application is not only complete but also tailored to meet the agency’s expectations for your product type, which streamlines the entire submission process.
Find a Good Communication Fit
A successful partnership depends on clear and consistent communication. Look for a firm that offers end-to-end support and works closely with your team every step of the way. A great sign is when a consulting firm assigns a dedicated project manager to your account. This gives you a single point of contact who understands your project inside and out, ensuring nothing gets lost in translation. You should feel like your consultant is an extension of your own team—someone you can trust to keep you informed and involved. Don’t hesitate to start a conversation early to see if their communication style is a good fit for you.
Check Their Support System
A great consultant does more than just prepare documents; they provide a robust support system that covers you from start to finish. This means they should help you prepare for critical meetings with the FDA, manage all communication with the agency, and be ready to respond quickly if regulators ask for more information. This proactive approach can prevent minor issues from escalating into major problems. Before signing a contract, ask about their process for handling FDA feedback and how they support clients after the initial submission. Their ability to help you manage the ongoing dialogue with the FDA is a crucial part of their role.
Analyze the Cost vs. Value
Finally, you need to consider the cost of consulting services in the context of the value they provide. IND submissions, especially for complex products like biologics, can be a significant investment. While it might be tempting to go with the lowest bidder, a cheap consultant who lacks the right experience could lead to mistakes that result in costly delays or even a clinical hold. Think of it as an investment in efficiency and risk reduction. A top-tier consultant might cost more upfront, but their ability to get your application right the first time will save you invaluable time and money in the long run. Ask for a detailed breakdown of their consulting services to understand exactly what you’re paying for.
How to Work Effectively With Your IND Consultant
Hiring an experienced IND consultant is a fantastic first step, but the real magic happens when you build a strong, collaborative relationship with them. Think of your consultant as an extension of your team, not just a service provider you hand tasks off to. Success depends on clear communication, shared goals, and a mutual understanding of the roles each of you plays. You bring the deep knowledge of your product, and they bring the regulatory expertise to chart the course.
To make the most of this partnership, you need to be an active participant. This means being organized, responsive, and open to their guidance. A great consultant will do more than just prepare documents; they’ll help you build a robust regulatory strategy that aligns with your business objectives. By working together effectively, you can streamline the submission process, avoid common pitfalls, and give your application the best possible chance of success. The following steps will help you establish a productive and efficient working relationship from day one.
Set Clear Expectations from the Start
The foundation of a great partnership is clarity. Before any work begins, schedule a kickoff meeting to align on the scope, timeline, and communication plan. This is your chance to define what success looks like for both sides. A common mistake is underestimating the time and resources needed for an IND, so be upfront about your budget and internal capacity. Your consultant can then help you create a realistic plan. Provide them with all existing documentation in an organized way, as disorganized information can cause significant delays. Establishing a clear project charter ensures everyone is on the same page about deliverables and deadlines.
Plan Your Project Milestones
An IND submission is a marathon, not a sprint. To keep the project manageable and on track, work with your consultant to break it down into key milestones. This roadmap should include deadlines for data collection, drafting specific sections of the application, and internal reviews. One of the most critical milestones is the pre-IND meeting with the FDA. This meeting is a valuable opportunity to get agency feedback before you formally submit your application. Your consultant will be instrumental in preparing for this interaction, but it’s a milestone that requires your team’s full attention and preparation to avoid a potential clinical hold later on.
Establish Quality Assurance
Your IND application is only as strong as the data supporting it. From the very beginning, you and your consultant should agree on a quality assurance process. This goes beyond a final proofread; it involves a thorough review of all your data to ensure it’s clear, accurate, and complete. An application can be weakened by using nonclinical data or manufacturing information that doesn’t adequately support the clinical protocol. Your consultant will act as a critical second pair of eyes, verifying that every claim is substantiated and that your results are presented logically. This commitment to data integrity is essential for building trust with FDA reviewers.
Create a Collaborative Partnership
The most successful IND submissions come from a true partnership between the sponsor and the consultant. Your team holds the invaluable scientific and product-specific knowledge, while your consultant provides the regulatory framework and strategic insight. The goal is to integrate these two areas of expertise. This involves creating a strong regulatory strategy that is directly linked to your product’s overall development plan. Schedule regular check-ins to discuss progress, address challenges, and make decisions together. An open line of communication and a willingness to build a strong client-consultant relationship will make the entire process smoother and more effective.
Set Yourself Up for Success
A successful Investigational New Drug (IND) application doesn’t happen by accident. It’s the result of careful planning, meticulous organization, and a strategic approach from day one. Think of it as building a house—you wouldn’t start putting up walls without a solid foundation. In the world of FDA submissions, that foundation is built on foresight and preparation. Many companies run into trouble not because their product lacks potential, but because they stumble over preventable process-related hurdles. Underestimating the complexity, disorganization, or a weak strategy can lead to delays, rejections, or costly clinical holds.
By focusing on a few key areas before you even begin compiling your submission, you can create a much smoother path toward approval. This means looking beyond the science and thinking critically about how you will present your data, manage your documentation, and align your development plan with regulatory expectations. Getting these elements right from the start saves you time, resources, and a lot of headaches down the road. It transforms the submission process from a frantic race to a well-managed project. Let’s walk through the four pillars that will support your application and set you up for a successful review.
Plan Early and Thoroughly
One of the most common mistakes in the IND process is underestimating the time and resources required. Starting early is non-negotiable. This gives you the space to map out your entire project, from preclinical studies to your final submission package. Engaging with consultants at the beginning of your journey can help you define a clear regulatory pathway and assess the feasibility of your timeline. An early start allows you to identify potential gaps in your data, address manufacturing challenges, and prepare for your pre-IND meeting with the FDA without rushing. This proactive approach helps you anticipate obstacles instead of just reacting to them, giving your application a much stronger chance of success.
Use a Solid Documentation System
Your IND submission is a massive collection of complex data, and how you present it matters. FDA reviewers are looking for a clear, logical, and easy-to-follow narrative. Including unnecessary information, disorganized data, and dense text are common missteps that can significantly slow down the review of your IND. A robust documentation system is your best tool for avoiding this. It ensures that every piece of information is accurate, traceable, and presented in a standardized format. This isn’t just about good housekeeping; it’s about showing regulators that you are thorough and professional. A well-organized submission makes a reviewer’s job easier and builds confidence in your data and your team.
Implement Strong Quality Control
The strength of your IND application rests on the quality of your data. A deficit of preclinical data can quickly discredit claims made about your product’s safety and efficacy. This is why strong quality control measures are essential throughout your development process. It’s not enough to simply conduct the required studies; you need to ensure the data is robust, reliable, and directly supports your clinical plan. You should create a strong regulatory strategy that links directly to your product’s development plan. This ensures that every study and every data point serves a clear purpose in building a compelling case for your investigational product.
Develop a Clear Compliance Strategy
A clear compliance strategy is your roadmap to FDA approval. It outlines not only how you will meet all regulatory requirements but also how you can use the system to your advantage. For instance, the FDA has several accelerated approval programs designed to speed up the review of innovative products that address unmet medical needs. A well-developed strategy will identify if your product qualifies for such programs and map out the steps to get there. This forward-thinking approach demonstrates to the FDA that you understand the regulatory landscape and have a viable plan for bringing a safe and effective product to market.
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Frequently Asked Questions
When is the best time to bring in an IND consultant? Ideally, you should engage a consultant much earlier than you think. The most effective time is when you are designing your final preclinical studies. Bringing an expert in at this stage allows them to help shape your development strategy to meet FDA expectations from the ground up. This is far more efficient than trying to package existing data that might not tell the right story, which can lead to costly fixes or additional studies down the road.
What’s the most common reason an IND application gets delayed or rejected? The most frequent issue isn’t a single error but a lack of a clear and compelling story. Applications often get delayed when the data is disorganized, the scientific reasoning is hard to follow, or the submission doesn’t directly address potential safety concerns. A clinical hold often happens because the FDA reviewer is left with more questions than answers. A strong application anticipates these questions and presents the information in a logical, easy-to-review format.
Is a pre-IND meeting with the FDA really that important? Absolutely. Skipping the pre-IND meeting is one of the riskiest shortcuts you can take. Think of this meeting as your opportunity to get direct feedback from the agency and align on your development plan before you invest significant time and resources into the final application. It helps you confirm that your preclinical data is sufficient and that your clinical trial design is sound, which dramatically reduces the chances of a clinical hold.
My team is already stretched thin. How much work is still required from us if we hire a consultant? Hiring a consultant is about making your team’s efforts more effective, not eliminating their involvement. Your team holds the essential scientific knowledge about the product. The consultant’s job is to take that knowledge and frame it within the complex regulatory requirements. They will handle the strategic planning, document preparation, and communication with the FDA, but they will rely on your team for the core data and scientific input. It’s a true partnership designed to streamline the process for you.
Can’t we save money by handling the submission ourselves? While it might seem cheaper upfront to manage the submission in-house, it can be a costly gamble. The IND process is incredibly complex, and a single mistake—like an incomplete dataset or a poorly designed protocol—can lead to a clinical hold. The cost of delaying your trial for months to fix these issues will almost always exceed the initial cost of hiring an expert. Investing in a consultant is an investment in getting it right the first time.