Pre & Post Approval CMC

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
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