We can deliver
Agency response support
Drafting responses to CMC deficiency letters and questions from EMA, MHRA, FDA and other authorities, with gap analysis of the underlying data.
CMC regulatory strategy
Development-phase CMC roadmaps aligned with ICH guidelines, defining the data package needed at each milestone and anticipating agency expectations.
Module 3 authoring & review
Preparation and critical review of CTD Module 3 (and Module 2.3 Quality Overall Summary) for MAAs, INDs, IMPDs and variations.
Comparability & tech transfer
Comparability protocols and regulatory support for process changes, site transfers and scale-up.
CMC gap assessments
Independent review of your CMC package against current guidelines to identify risks before submission or inspection.
Variations & lifecycle management
Classification, preparation and submission of post-approval CMC changes, including grouping and worksharing strategies.
Biotech companies preparing their first IND/IMPD or MAA
Established pharma teams needing surge capacity for variations
Companies responding to CMC deficiency letters
Programmes undergoing tech transfer or manufacturing changes
Relevant expertise
ICH Q1–Q14 quality guidelines
CTD Module 3 and Quality Overall Summary
EMA, MHRA and FDA CMC requirements
Stability programmes and shelf-life justification
Process validation and analytical method validation
Post-approval change management (PACMPs)