Global Regulatory [Regulated & Emerging Markets]
- Build Global Regulatory Strategies
- Build Clinical Development Strategies
- Build Formulation Development Strategies
- Technical/Consultancy support during pre-IND/NDA, Scientific advice with regulatory agencies
- Due Diligence of dossiers for global markets
- Authoring administrative (m1) and technical sections (m2 to m5) of dossier (CTD format) eCTD Publishing services for CTD dossiers
- Life-cycle management services (variations / post-approval changes)
- Support during the technical query response from the regulatory agencies.
- Review of technical (CMC) documents, bioequivalence protocol and clinical study protocols.