Pharmaceutical Regulatory Affairs in Brazil
Business / by DDREG Pharma / 6 views / New
The page outlines how the company assists global and local pharmaceutical firms in navigating the regulatory requirements set by ANVISA (Agência Nacional de Vigilância Sanitária). Key services described include:
End-to-End Drug Registration: Support for new drugs, generics, biologics, and “similar” products.
Local Representation: Providing Brazilian Registration Holder (BRH) support for foreign companies.
Dossier Management: Preparation and submission of registration dossiers (CTD/eCTD formats) and gap analysis.
Lifecycle Management: Handling post-approval needs such as renewals, variations, and compliance monitoring.
Strategic Consulting: Guidance on priority review pathways, GMP certification support, and regulatory intelligence.
Essentially, the page positions DDReg as a specialized consultancy that helps companies manage the technical and legal complexities of entering and maintaining a presence in the Brazilian pharmaceutical market.
- Listing ID: 58223