Is your Biotech considering applying for an expedited FDA Regulatory Affairs program (e.g., Orphan Drug designation, Fast Track designation, or Breakthrough Therapy designation, among others)? Or perhaps your team has a nonclinical package and is prepared to engage the FDA for a Pre-IND Meeting or is needing to develop the IND itself. If so, BioPharma Global, a full-service consulting firm focusing exclusively on regulatory affairs, can provide support for these and many other regulatory advisory service needs.
For more information see our white paper on the “Benefits of Working with BioPharma Global” at:
https://www.biopharmaglobal.com/the-benefits-of-working-with-biopharma-global-white-paper/