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US Regulatory Affairs
- Detailing the expectations of the US FDA, its structure and operating logistics
- Advising on regulatory and product development plans and strategies
- Arranging and preparing meetings at the FDA for all stages of your development program:
- Orphan Drug Designation
- Pre-IND
- End-of-Phase II
- Pre-NDA
- Post-Approval
- Preparing, reviewing, and submitting FDA required documentation including:
- Orphan Drug Designation Requests
- Investigational New Drug Applications (IND)
- New Drug Applications (NDA)
- Abbreviated New Drug Applications (ANDA)
- Biologics Licenses (BLA)
- Drug Master Files
- Establishment Registration and Product Listing
- Citizen’s Petitions
- Acting as a US Agent for regulatory filings on behalf of foreign firms
- Identifying regulatory requirements and strategies for pre- and post-approval activities in component sourcing, product formulation, manufacturing and validation, packaging, labeling, testing, specifications, and stability
- Preparing for, and participating in, FDA inspections including action plans for follow-up of FDA observations and wning letters
- Performing due diligence review of regulatory files and strategy for acquisitions and in-licensing
Back to Expertise
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Bruce E. Thompson, BSc, MBA
28 Hungerford Terrace
Burlington, VT 05401
(802) 865-0261
bthompson@REGULIANCE.com |
