Free 30-minute regulatory scoping call for biotech and pharma startups — specialising in ATMP/CGT, biologics and small molecules
CMC Regulatory Consulting
Minerva provides expert CMC regulatory strategy and documentation authoring for biologics — including advanced therapy medicinal products (ATMPs) and cell and gene therapies (CGTs) — as well as small molecules. We work across MHRA, EMA and FDA regulatory frameworks, supporting programmes from IND/CTA initiation through to NDA, BLA and MAA submission in the UK, EU and US.
Whether you are preparing for your first clinical trial application or managing a complex multi-region marketing submission, Minerva provides the senior-level CMC expertise to build a robust, submission-ready dossier.
Not fully confident in your CMC regulatory strategy ?
Phase-appropriate global CMC regulatory strategies aligned with MHRA, EMA, FDA and ICH guidelines — from IND/CTA initiation through clinical progression to marketing applications including NDA, BLA and MAA.
CMC Documentation & Authoring
High-quality CMC dossier preparation and critical review, including Modules 2.3 and 3 and IMPD-Q sections for IND, CTA, NDA, BLA and MAA submissions. All documentation authored to the standard expected by MHRA, EMA and FDA reviewers.
CMC Readiness Assessment
Comprehensive gap analysis of CMC data packages to identify deficiencies, de-risk regulatory milestones and confirm readiness for agency interactions and submissions. Particularly valuable ahead of Type B meetings, Scientific Advice or pre-IND/pre-CTA interactions.
Specialist Support
Agency Response Writing
Scientifically justified, clearly structured responses to regulatory authority queries — including MHRA, EMA and FDA information requests — to support timely review and progression of clinical and marketing applications.
Technical Report Review
In-depth assessment of analytical, manufacturing and quality documentation for consistency, accuracy and regulatory alignment. Covers method validation reports, batch records, stability data packages and comparability protocols.
Agency Meeting Preparation
Strategic planning and preparation for Scientific Advice, Type B and Type C meetings and other regulatory interactions — including briefing package development, Q&A preparation and meeting strategy.
Stability, Specs & Changes
Expert guidance on stability strategy, specification setting and justification, and lifecycle management of manufacturing changes under MHRA, EMA and FDA requirements. Includes post-approval variation support.
