Drug’s Approval

Get clear on investigational new drug application requirements with practical tips for a strong IND submission and a smoother FDA review process.

505 pathway consulting helps you save time and resources by guiding your drug through the FDA’s 505(b)(2) approval process with a tailored strategy.

Get practical tips for IND preparation, from preclinical studies to FDA submission, and learn how to build a strong application for your clinical trial.

Get the pdufa date definition fda uses, plus a clear breakdown of the PDUFA timeline, key phases, and what each deadline means for your drug application.

Gaining orphan drug designation offers market exclusivity and tax credits. Learn the criteria and steps to secure orphan drug status for your product. Read our guide.

Get expert orphan drug designation consulting with our guide. We cover the application process, FDA requirements, and how to secure market exclusivity. Read more.

Learn the essentials of an investigational new drug (IND) application, from key sections to the FDA review process. Prepare your IND submission with confidence.

Get clear, actionable steps for bioequivalence study design, from protocol planning to regulatory approval, with tips for reliable, submission-ready results.

Get clear answers to what is breakthrough therapy designation, how it works, who qualifies, and the steps to secure this FDA status for your new drug.

Get your fast track FDA application right with our guide. We cover the criteria, documentation, and step-by-step process for a successful submission. Apply now.