Regulatory Affairs
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Regulatory Affairs is a critical function that ensures products comply with all applicable
Overview
Regulatory Affairs
Regulatory Affairs is a critical function that ensures products comply with all applicable laws, regulations, and guidelines set by national and international regulatory authorities. It acts as a bridge between organizations and regulatory bodies to facilitate safe, effective, and compliant product development and commercialization.
Regulatory Strategy
- Regulatory Consulting/Strategic services
- Health Authority interactions/Pre-submission meetings
- Regulatory Submission Road Maps/Regulatory Intelligence Services
- Dossier Templates for the U.S. and the EU Regulatory Submissions
- TGA Marketing Authorization Application (MAA)
- Biologics Registration Services - RoW
- Regulatory Compliance and Gap Analysis
- Post-Approval Changes Submissions
- Lifecycle Management (LCM)
- Regulatory Staffing Services
- Clinical Trial Applications (CTAs) For Global Countries
- Regulatory Affairs Services
- Brexit-related Regulatory Support
Why Choose Us
Global Health Authorities
US FDA Regulatory
- Abbreviated New Drug Application (ANDA) Submissions
- Biologics License Applications (BLA)
- Drug Master File (DMF) Submissions
- NDA 505 b (1) and 505 b (2)
- Investigational New Drug (IND) Applications
Health Canada Regulatory
- Abbreviated New Drug Submission (ANDS)
- New Drug Submission (NDS) for Canada
- Drug Master File (DMF) Submissions
- Clinical Trial Applications (CTAs) For Global Countries
European HA's
- Active Substance Master File (ASMF) Submissions
- Investigational Medicinal Product Dossier (IMPD)
- EU Marketing Authorization Application (MAA)
- Certification of Suitability (CEP) Submissions
- Decentralized Procedure (DCP)
- Mutual Recognition Procedure (MRP)
- National Procedure (NP)
- Centralised Procedure
