Pharmaceutical, and Biotechnology Toxicology Study

Toxicology Consulting Services for the Life Science Industry

During the preclinical phase of a drug or life sciences product, you are required to conduct a toxicology studies to assess potential health risk associated with a new product. But how can you know which type of preclinical toxicology report is best to perform your product? And how can you be sure that you are meeting each guideline as set forth by the Federal Food and Drug Administration (FDA)? This is where JJCC Group can help you.

Attain regulatory approval for your product in the Life Science with the help of JJCC Group consultants. Our board-certified toxicologists, scientists, researchers, statisticians, and expert regulatory compliance consultants boast years of experience in process development of life science products and protect human health through regulatory compliance oversight.

Our toxicology consulting services include (but are not limited to):

● Toxicology study design
● Health Risk Assessment of drug and other life science products
● Full toxicology reports
● Safety Data Sheet.

What is a Toxicology study?

A toxicology study (in-vitro vs. in-vivo) is a conducted on a drug, or a life science product to assess potential risk of such a drug, medical devices or other life science product on living subjects, from rodents to humans. Toxicity testing can be very specific for a particular effect, such as dermal irritation, or it may be general, such as testing for unknown chronic effects. standardized tests have been developed for the following effects:
• Acute Toxicity
• Sub-chronic Toxicity
• Chronic Toxicity
• Carcinogenicity
• Reproductive Toxicity
• Developmental Toxicity
• Dermal Toxicity
• Immunotoxicity.
• Ocular Toxicity
• Neurotoxicity
• Genetic Toxicity

Why do I Need a Toxicology Study?

The entire purpose of a toxicology study is to determine whether or not your drug could be harmful to future consumers. Before an organization can enter the clinical trial phase for their pharmaceutical product or other life science product, they must first run studies and determine whether or not this drug could be potentially harmful to people, the environment, or animals.

However, abiding by good laboratory practice (GLP) guidelines set forth by the Food and Drug Administration can be taxing, time-consuming, and costly. These guidelines set high standards for equipment, processes, testing procedures, and more. Hiring regulatory compliance consultants to ensure you are able to run a thorough toxicology report that satisfies each requirement by the FDA and other regulatory bodies (including the EPA or OECD) may pay you in dividends.

Receive regulatory compliance assistance in toxicology reporting and gain full approval of food products, pharmaceutical industry products, and other life science products with JJCC Group’s expert regulatory compliance consultants. We’ll help you bring your product to (daily) life.

Medical Device Regulatory Compliance Specialists

A singular mistake or oversight in your medical device regulatory strategy can have a direct and negative impact on your business. With JJCC’s assistance, rest assured that your medical device company produces a high quality product that meets each and every medical device regulation standard necessary to bring it safely to the American, canadian and other international markets.

The development, manufacturing and distribution of medical devices requires strict adherence to many regulatory compliance standards, such as the ISO 13485 and FDA 21 CFR part 820, Canadian regulation SOR/98-282 among other. JJCC Group helps you from your product’s conception to the very end of your medical device’s lifecycle, preventing oversight, proactively predicting compliance issues, and allowing you optimize your product, its production, and your processes. We guide you through each stage of the medical device regulatory compliance process, and offer a wide variety of industry-specific services to assist you during planning, production, and post-market approval implementation.

Medical Device Development & Regulatory Strategy Consulting

We’ll coach you through the best strategies to ensure your medical device meets all national and international regulations. No matter which stage you are in in the due diligence process of bringing a medical device to the United States and international markets, we can provide you with every strategy and resource necessary to bring your product to life in the most streamlined and coherent manner.

At JJCC Group, our consultants work hard to solidify your:

– New product design and development.
– Product manufacturing and packaging
– Production specification and requirement
– Equipment and processes Validation and verification
– Risk assessment and Risk Management
– Staff training ( cGMP, ISO, safety, …etc).
– Manufacturing optimization.

Quality Assurance & Quality Control

To assess your manufacturing and processes capacity and capability, risk assessments, audits, and inspection and regulatory agency action responses. The FDA requires detailed documentation proving the efficacy of your product, its handling, its shipping, and much more. JJCC Group’s 30 years of condensed industry knowledge

– Quality assurance audits: We will assess and inspect all current and future manufacturing practices and determine whether or not all regulatory requirements are being met.

– Testing: JJCC Group’s consultants will help you test and identify the equipment and tools that may not be working in your manufacturing process to optimize your product’s life cycle. We’ll also help you understand whether or not these tools and equipment meet regulatory compliance requirements.

– Staff training: Be sure that your staff members are prepared to practice and abide by all regulatory compliance standards in each stage of your product’s life cycle with JJCC’s staff training.

– Corrective and preventive action (CAPA) management: With our help, you’ll be able to discover systemic flaws and identify kinks in each of your internal processes before they have a significant negative impact on your business.

– Risk Management: Meeting ISO 13485 requirements for documentation, design, development, production, and more can be a grueling experience. However, JJCC Group’s 30+ years of medical device regulatory compliance knowledge and expertise will provide you with customized blueprints to achieve this feat. Our quality assurance experts help you by providing assistance with various factors of medical device development including (but not limited to):

● Gap Assessment.
● ISO 13485 Quality System Implementation & Transition.
● Standard Operating Procedure (SOP) Development
● Assistance meeting CE mark requirements.
● Document Control Implementation.

Ensure that your manufacturing processes are pristine and optimally effective with the help of JJCC Group. Reach out to one of our compliance experts today for a free consultation.

Sources:

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

ISO 13485:2016

https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices

Dietary Supplement Regulatory Compliance Consulting Services

Throughout the past 10 years, the dietary supplement industry has been under increasing scrutiny regarding the safety of its products. Federal bodies and quality bodies Therefore, companies aiming to produce and distribute natural and synthetic dietary supplements to the public must follow strict guidelines and meet various requirements to verify that their product is both safe and backs up each of its health claims.

JJCC Group is a leading regulatory consultant agency in the life science industry. We serve companies across the entire United States, helping organizations in the dietary supplement industry adhere to the Dietary Supplement Health and Education Act (DSHEA) and various other federal and industry-specific regulations.

Nowadays, more than ever, it is critical to ensure that each stage of your dietary supplement’s creation – from safety programs, to labeling, to dispersion and sales, to manufacturing and distribution – is pristine.
We will help your company develop thorough regulatory strategies for your dietary supplement product. We’ll also assist with the following:

– Supply chain management.
– Dietary supplement labeling.
– Federal Food and Drug Administration (FDA) requirements
– FDA audits.
– Food safety programs set-up and implementation.
– Submission of New Dietary Supplement Notifications.
– Generally Recognized as Safe (GRAS) submissions.
– Employee training.
– Clinical trials.
– Adverse event reporting.

Dietary Supplement Labeling & Substantiating Health Claims

JJCC Group advises firms on their manufacturing, marketing, or distribution process of dietary supplements. JJCC Group will design and conduct clinical trials for raw materials or finished products if your company’s intent is to prove the efficacy and safety of your supplement.

Many manufacturers that do not comply with labeling guidance will experience various roadblocks when trying to gain FDA approval of their product. JJCC is meticulous in designing comprehensive clinical studies to validate any claims made on your dietary supplement labels. JJCC Group consultants will ensure that each dietary ingredient label and insert adheres to all necessary FDA regulations to further minimize your organization’s risk and optimize your product development journey.

Current Good Manufacturing Practice (CGMP) Regulatory Consulting

JJCC Group helps you perfect each stage of your dietary supplement manufacturing, from packaging, labeling, and holding operations. We help clients develop and comply with regulations regarding the 21 CFR part 111. If you are seeking guidance, advisement, or assistance in bringing your dietary supplement to full fruition, reach out to JJCC Group. Our consultants will help you optimize your internal processes and bring your product to the United States market – without typical compliance roadbumps.

Quality Management System Regulatory Management Consultants

The cost of a poor quality management system can negatively impact on your business’s sales, operations, and reputation. JJCC Group consultants measure your success in results. Our scientists, physicians, and life science industry leaders help you produce fully-compliant and profitable products in the pharmaceutical industry, food and beverage industry, and other life science industries.

JJCC Group transforms businesses and optimizes the internal processes of manufacturers in the life science industry through our Quality Management System (QMS) consulting services. With our tremendous experience in the creation and implementation of quality management systems, you can rest assured that your methods of using technology, software, data, and equipment is the most efficient and cost-effective structure possible for your product.

Creating an exceptional Quality Management System is critical to satisfying your customers and ensuring that your operating policies and procedures abide by all regulatory requirements, promote efficiency, and support long-term growth.

How JJCC Group Propels Your Business

At JJCC Group, we tailor our consulting services to fit the needs of your business. A business in the pharmaceutical industry likely has a variety of different and unique requirements than a company producing medical devices. Our quality management consulting extends far past the creation of a quality management system at your company. Instead, we are with you from the very beginning of your QMS design, to regulatory compliance approval, and finally to the end of its full implementation in your product’s production process.

Our quality management consulting services offer clients a wide variety of instructional services, technical experience, and tangible experience. We are able to view your company from an industry-wide lens and help you effectively reform your company’s internal processes related to design, manufacturing, and more.

JJCC Group will help your business:
● Design and implement your QMS.
● Ensure high-quality record-keeping and documenting.
● Abide by all FDA requirements.
● Ensure full quality compliance.

Instead of attempting to create and apply a partially-compliant quality management system in your business, why not save heaps of time and money by taking advantage of our team of experts’ extensive life science industry experience? Ensure that your business is operating in the most cost-effective manner and that your manufacturing process is fully compliant with the help of JJCC consultants. No matter what stage of development your product is in, we can help you achieve full compliance, fine-tune your policies, and optimize your internal processes. Reach out to JJCC Group today to learn more about our services and how we can customize our offerings to fit the specific needs of your business.

Clinical Trial Regulatory Compliance Consulting Services

Clinical study requires meticulous planning and careful execution. Failure to adhere to well-thought study protocol/regiment, may lead to a waste of resources including time and money.

By partnering with JJCC Group, you avoid this pitfall, accelerate the drug discovery and product development and attain premarket authorization to market your product in a timely fashion.

JJCC Group brings a decades-dense knowledge pool of JJCC Group’s expertise to develop, design, and execute clinical study while monitoring and managing all phases of the study.

Our clinical development team will guide you through each stage of the clinical trial planning and development process.

JJCC Group will help you conduct a clinical trial for your product. With the help of JJCC Group’s consultants, you’ll be able to thoroughly understand and wisely employ the strategic secrets to a successful clinical and gain FDA approval.

Clinical Trial Process: Planning & Conduct

JJCC Group’s team of clinical trial experts is composed of scientists, researchers, toxicologists, statisticians, and regulatory professionals among others. We’ve guided hundreds of clients through the process of clinical trials in various healthcare industries and other therapeutic areas. JJCC Group’s clinical trial experts will help you with various stages of your clinical trial execution with targeted services including (but not limited to):

● Developing, planning and monitoring clinical trials
● Recruiting, screening and qualifying participants.
● Medical writing and submission of clinical reports.
● Regulatory submission

Consumers deserve to see your ethical, compliant, and beneficial product brought to national and international markets. Achieve full compliance for your medical device, pharmaceutical drug, vape product, tobacco product, or other life science product with the help of JJCC Group’s regulatory compliance experts.

Conduct your clinical trial in an ethical, cost-effective, and optimized manner with JJCC Group’s team of clinical trial experts. Reach out to us today for more information on our regulatory consulting services, drug development assistance, regulatory affairs consulting, and drug application assistance.

Employee Training Regulatory Compliance Consultants

Reduce risk and propel your business forward with JJCC Group’s regulatory compliance experts. We offer cost-effective compliance systems that optimize your production process and support your valuable team of staff members.

There is more to quality management and regulatory compliance than production processes. Ensuring quality in a life science business and its products also requires a deep delve into your company’s work culture, ethics, and human resources practices.

Compliance Training in the Life Science Industry

Once you’ve established a pristine quality management system, conducted clinical trials, assessed toxicology reports, and taken care of other mechanical aspects of your business’s life science product, it’s vital to assess those who breathe life into your product: your employees.

Without a staff force of motivated, ethical, and knowledgeable employees that feel both supported and challenged by your company’s culture, your product will fail to reach its highest potential.

JJCC Group is staffed full of clinical experts, compliance gurus, scientists, and physicians. However, we also contain one sector of specialization that sets us apart from other regulatory compliance agencies: we care about your people and we understand that, without optimizing your employees’ processes and ensuring a healthy work culture, your product may fail.

Compliance Training & Consulting: What We Do

Our consultants provide you with a customized compliance training program that helps your employees learn everything vital about the production of your product. To protect your employees, we provide you with various industry-specific training solutions that focus on ensuring that your employees fully understand the policies, procedures, and operational processes that dictate your product’s production.

Compliance training saves your business time and money. Compliance training enables your business to become an efficient, cost-effective, and fully-compliant machine.

We provide employee training consulting in the following staff-related areas:
– Company vision, values, and ethics.
– Company policies and procedures (and the way employees understand and abide by these policies and procedures).
– Overall professionalism in a life science industry workplace.
– The optimization of position-specific employee processes.

Propel Your Business Forward with JJCC Group Regulatory Consultants

At JJCC Group, we don’t just consult your company on its operation processes, regulatory compliance issues, and scientific studies – we also work feverishly to ensure that your business is holistically optimized on a company-wide level.

With our help, you’ll be able to ensure your company’s culture is compliant with all procedures, values, and policies.