Pharmaceutical Regulatory Affairs in Brazil
ID: #90952
Listed In : Health Care Consultants
Business Description
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.
Business Hours
Monday : 09:00 - 17:00
Tuesday : 09:00 - 17:00
Wednesday : 09:00 - 17:00
Thursday : 09:00 - 17:00
Friday : 09:00 - 17:00
Saturday - Closed
Sunday - Closed