Overview
MAVEN, a leading Regulatory services provider, has the experience and expertise to handle different phases of Drug, Vaccines and Biosimilar registration, from development to dossier Gap Analysis, Preparation and Submission to Lifecycle management.
Expertise
Our services at different stages of drug development include:
- Development Stage
- Pre-submission Administrative Activities
- Regulatory Assessment/Gap Analysis
- Authoring Regulatory Documents
- Compilation, Review & Submission
- Response to Health Authority Queries
- Submissions for Post-Approval Changes
- Lifecycle Management Services
Advantages
- Cost-effective
- End-to-end Regulatory consultation
- Qualified team of experts with hands-on experience across all categories of Pharmaceuticals (Generics & Innovator Drugs), Biologics (Biosimilars & Vaccines)
- Expert support for region-specific Regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach to ensure quick product launch or market access
