CMC & Regulatory Affairs · Biologics · ATMPs/CGTs · Small Molecules
Expert CMC and regulatory expertise, exactly when your programme needs it
Whether you're a startup building your first regulatory strategy or an established team tackling a complex ATMP, CGT or broader biologics and small molecule submission — Minerva provides the specialist depth to move faster and submit with confidence
Your Partner in Regulatory Success
ATMP / CGT - Biologics - Small molecules - GMO applications - IND & CTA submissions
Our Role
Minerva Regulatory Consulting's mission is to accelerate drug development across biologics — especially advanced therapies (ATMPs/CGTs) — and small‑molecule products by delivering specialised CMC expertise, high‑quality regulatory submissions, and end‑to‑end GMO application support.
We help organisations move faster and more confidently through global regulatory pathways with strategies that are clear, actionable, and commercially focused.
With a practical, implementation‑driven approach, we turn complex regulatory requirements into actionable strategies — enabling faster approvals, smoother lifecycle management, and stronger commercial outcomes.
Unsure of your regulatory path?
About
Minerva Regulatory Consulting supports organisations as they transition from early scientific development into high‑expectation regulatory environments, where clarity, structure, and global readiness become essential. In biologics, ATMPs, and GMO‑regulated products, success depends not only on scientific strength but on the ability to demonstrate regulatory alignment, CMC robustness, and consistent execution under increasing scrutiny.
Minerva is led by Dr Lara Stevanato, a Strategic Regulatory Affairs Leader with over 20 years of experience across biotech and CRO settings. She has delivered complex global regulatory strategies for biologics such as ATMPs/CGTs, GMO applications, and small molecules, guiding programmes from early development through to approval. Her expertise spans high‑complexity submissions, hands‑on operational leadership, and strategic engagement with MHRA, EMA, and FDA. Dr Stevanato brings deep experience navigating evolving regulatory frameworks, identifying risks, and shaping strategies aligned with both development and commercial objectives.
Minerva Regulatory’s approach is grounded in practical regulatory enablement— implementing solutions that are proportionate, sustainable, and embedded within existing operations. The company ensures organisations are prepared to meet rising regulatory expectations with confidence, supporting their progression into the next stage of growth and product advancement.
Dr Lara Stevanato
Services
CMC Regulatory
High‑quality documentation built to meet global authority expectations and withstand increasing scrutiny.
GMO framework navigation
Technical & Medical Writing
Regulatory Affairs -ATMP/CGT Specialist
Expert support to help navigate the complex GMO regulatory framework, ensuring compliant, well‑structured dossiers and smooth authority engagement.
Turn complex CMC requirements into clear, actionable strategies that reduce uncertainty and accelerate decision‑making.
Phase‑appropriate regulatory planning that supports smoother interactions with MHRA, EMA, and FDA.
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.
Not fully confident in your CMC regulatory strategy ?
Not certain about your regulatory pathway?
Regulatory Affairs Service
Global Submission Strategy
Development of coherent, multi‑region regulatory strategies aligned with MHRA, EMA, FDA and ICH expectations.
Support includes planning for IND/CTA initiation, clinical progression, and MAA/NDA/BLA pathways, ensuring harmonised documentation across regions.
Agency Interaction
Strategic preparation for Scientific Advice, Type B/C meetings and other regulatory engagements.
Includes development of Briefing Books, meeting packages and clear communication strategies to facilitate productive dialogue with authorities.
Regulatory Intelligence
Continuous monitoring of evolving guidance, policy updates and global regulatory trends to proactively inform development plans and mitigate emerging risks.
Submission Authoring
Expert preparation, authoring and critical review of regulatory dossiers to ensure clarity, consistency and compliance
Support for CTIS applications, dossier compilation and submission‑ready documentation.
Post‑Approval Support
Lifecycle management of authorised products, including variations, renewals, labelling updates, and regulatory maintenance activities to ensure ongoing compliance.
GMO Application Service
Not fully confident in your GMO regulatory pathway?
GMO application preparation
Authoring and review of environmental risk assessments (ERA), GMO technical dossier, and supporting documentation for contained use, deliberate release for clinical trial applications.
Integrated CMC–biosafety–environmental strategy
Consolidation of CMC, biosafety, and environmental risk considerations into a single, coherent strategy to support GMO requirements for clinical trial applications.
Facility & process description support
Preparation of detailed descriptions of manufacturing sites, containment measures, and operational controls required for GMO submissions.
Submission management
Coordination and management of global GMO submission processes, including compilation, formatting, submission to biosafety authorities, and tracking of review timelines and follow‑up requests
Technical Writing Service
Manufacturing & Analytical Report Review
Manufacturing process descriptions
Batch records and manufacturing summaries
Analytical method qualification/validation reports
Specifications and justification documents
Stability reports and trending summaries
Comparability protocols and reports
ATMP/CGT
Comprehensive authoring and critical review of ATMP/CGT technical documentation, including viral‑vector and cell‑processing reports, comparability packages, potency‑assurance justifications, and analytical/manufacturing summaries to ensure clarity, consistency and regulatory alignment.
Informed Consent–Related Writing
Authoring and customisation of Informed Consent Forms (ICFs)
Localisation and adaptation for country‑specific ethics committee requirements
Consistency review against protocol, Investigator Brochure, and patient‑facing materials
Plain‑language optimisation for readability and regulatory compliance
Need technical writing support to strengthen your documentation?