USA
The U.S. Food and Drugs Administration (USFDA) establishes the regulatory framework governing the registration and commercialization of drug products in the United States. Navigating this intricate and time-consuming regulatory pathway can be challenging. Our consulting team specializes in offering expertise across all facets of the FDA's lifecycle management.
Services We Offer
- Regulatory intelligence & regulatory strategy
- Expert reports in line with current regulations
- DMF review
- Preparation, review, submission & registration of dossiers
- Gap analysis
- US Agent Services. (Human & Veterinary)
- Query responses
- Evaluation & submission of post-approval changes
- Labeling & Artworks
- Lifecycle Management – annual reports, supplements, amendments
- Establishment registrations and Product listings
- Publishing and gateway submissions