The United States Food and Drug Administration (USFDA) is one of the world's most stringent regulatory authorities. Gaining and maintaining FDA approval requires meticulous dossier compilation, deep knowledge of 21 CFR requirements, and rigorous quality systems. RBridge Lifesciences brings hands-on USFDA experience to support your US market entry and lifecycle management.
What We Offer
- Gap Assessment
- Dossier Compilation, Review, and Preparation
- USDMF Preparation and Filing
- Post Approval Changes (PAS, CBE-30, CBE-0, AR)
- ANDA and NDA Support
- Inspection Readiness and Liaison Support
Key FDA Regulatory Framework
- 21 CFR Parts 210 and 211 govern cGMP for finished pharmaceuticals
- Drug Master Files (DMFs) protect confidential manufacturing information submitted to FDA
- Generic drug applications (ANDAs) must demonstrate bioequivalence and pharmaceutical equivalence
- FDA conducts pre-approval inspections (PAIs) and periodic surveillance inspections
- Electronic submission via FDA ESG is standard; eCTD format required for most submissions