G&L Pre & Post Approval CMC Offering:
Technical CMC expertise lies at the very heart of G&L’s offering, from a strategic and operational perspective. Deep domain experience across the entire product lifecycle and across multiple product types, G&L has the scalability to manage projects and engagements of any size.
Pre-Approval:
- Strategic drug development, support and guidance
- Authoring of CMC CTD documents for INDs, 505(b)2, NDA, BLA, ANDA and post-approval submissions
- Support of FDA meetings
- Gap analysis, mitigation and remediation
- Act as confidential DMF liaison
- Document Authoring:
- Module 2.3 Quality Overall Summary
- Module 3 Quality
- Support of pre-submission meetings
- Responses to review questions, ad-hoc inquiries
- Preparation of briefing books/background packages
- Support of scientific advice meetings
- Monitoring/tracking of commitments
- Drug development support to meet regulatory, technical and quality requirements at each phase of the product lifecycle
- Commercial product initiative support
- Address regulatory agency CMC concerns
- Agency negotiations to facilitate CMC approvals
- Mitigate risk and address gaps in documents/data
- Regulatory Intelligence
Post Approval CMC
- Follow-on submissions for Rest-of-World (ROW) markets
- Dossier conversions
- Dossier updates
- Functional Service Provider:
- US Annual Reports
- International License Renewals
- Variations
- Yearly Biologic Product Report (YBPR)
- Preparation of supplements, line extensions etc.
- Document Authoring:
- Module 2.3 Quality Overall Summary
- Module 3 Quality
- Portfolio Management
- CMC Compliance Reviews & Remediation
- Due-diligence
- Manufacturing site transfers
- Manufacturing site closures
- Change of Ownership applications