Regulatory Affairs

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

G&L License Maintenance Offering:

G&L has extensive experience in performing license maintenance activities for our clients on a global basis, not only fulfilling the license holder’s obligations and minimizing future compliance risks but also successfully realizing additional revenue streams for marketed products through line extensions, product reclassification and new market approvals.

• Renewals and Annual Reports
• Line Extensions
• Variations and Amendments
• Geo-expansion

G&L Dossier Preparation & Submission Offering:

Carefully-considered, well-written and comprehensive submission packages are a central factor in achieving regulatory approvals in a timeline manner. G&L has a wealth of experience in compiling, authoring and publishing regulatory submissions across all product types and markets, as well as liaising with, and submitting to all major regulatory agencies across the globe.

• Authoring of CTD Modules 1-5 (or equivalent)
• eCTD Publishing
• Local/Portal Submissions

G&L Global Regulatory Intelligence & Strategy Offering:

Access to current, validated and first-hand Regulatory Intelligence has never been so important in order to successfully navigate approval pathways across new markets and product types. G&L’s experts will work closely with you to understand and achieve right-first-time submissions and faster approvals.

• Local Regulatory Requirements
• Agency/Advisory Committee meetings
• Scientific Advice and Protocol Assistance

G&L Special Regulatory Projects Offering:

G&L’s team has a proven track-record of delivering high-profile, global and transformative projects to our clients in a manner that is synergistic with “business as usual” activity – includes M&A integration, CMC Compliance initiatives, manufacturing site rationalization, due-diligence and divestment.

Suggested content:

• M&A Integration
• CMC Compliance
• Manufacturing Site Rationalization
• Site Transfers
• Change of Ownership
• Due-Diligence and Divestment
• CTD Builds