FDA & Global Regulatory
"We are clinical pharmacologists and drug developers with innate ability to aid in solving drug development challenges and developing straight forward strategies for successful therapies."
Vanadro’ approach to interactions with the regulatory authorities is to utilize years of experience in scientific, clinical, nonclinical, and overall drug development and strategy to be able to successfully support initial approval as well as marketing approval and market success.
We believe that successful interactions with regulatory authorities are a critical component to a successful drug development program. This can be best achieved by a realistic strategic assessment of the strengths and weaknesses of each individual program. Our ability to look at the program from many different sides aids in a more holistic strategy and development assessment. We can attend meetings with the FDA for and with our clients (e.g., Pre-IND, end of Phase 1 [EoP1], end of Phase 2 [EoP2], pre-NDA, pre-BLA). We have an understanding of current FDA expectations and with that have been able to determine issues of critical importance to the FDA and other regulatory agencies to be able to advise our clients on best path forward in development of their molecules and the challenges they may be faced with.
As part of our interactions with the FDA, we have participated in teleconferences, face-to-face meetings, and written correspondence with FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) Hematology and Oncology Drug Products (OHOP) primarily.
- IND CTD / eCTD Module 2
- Especially 2.4 Nonclinical Overview, 2.5 Clinical Overview, 2.6 Nonclinical Written and Tabulated Summaries, 2.7 Clinical Summary (2.7.1 and 2.7.2 Biopharmaceutics and Pharmacology)
- FDA / EMA / PMDA Meetings, teleconferences and written correspondence
- Meeting management and attendance
- Briefing document preparation
- Attend FDA / EMA / PMDA meetings as a subject matter expert (clinical pharmacology/PK, toxicology, development representation at regulatory meetings)
- Investigator Brochure authoring and updates
- IND annual reports
- Clinical trial protocols and Clinical Study Reports (CSRs)
- IND/NDA/BLA submissions (all modules)
- Investigational Medicinal Product Dossiers (IMPD) and other international regulatory documents
- Pediatric Study Plans (PSPs) and Pediatric Investigational Plans (PIPs)