Drug’s Approval

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.

Get clear on FDA Type B meetings and how fda meeting preparation consulting can help you avoid costly mistakes and move your product forward with confidence.

Get expert IND submission consulting advice to navigate the FDA’s 30-day safety review and prevent costly clinical holds. Prepare your application for success.

Navigate the complex IND submission process with our expert guide. Learn how to prevent clinical holds and prepare a successful FDA application. Read more.