CMC Regulatory Service
Core Capabilities
CMC Regulatory Strategy
Phase-appropriate global strategies aligned with MHRA, EMA, FDA and ICH guidelines — from IND/CTA initiation through marketing applications.
CMC Documentation & Authoring
High-quality CMC dossiers, including Modules 2.3 and 3/IMPD-Q, for IND, NDA, BLA, CTA and MAA submissions.
CMC Readiness Assessment
Gap analysis of CMC data packages to identify deficiencies and de-risk regulatory milestones before submissions and agency interactions.
Specialist Support
Agency Response Writing
Scientifically justified responses to regulatory queries to support timely review and application progression.
Technical Report Review
Assessment of analytical, manufacturing and quality documentation for consistency, accuracy and regulatory alignment.
Agency Meeting Preparation
Planning and preparation for Scientific Advice, Type B/C meetings and other regulatory interactions — including briefing packages and meeting strategy.
Stability, Specs & Changes
Guidance on stability strategy, specification justification and lifecycle management of manufacturing changes.