Free 30-minute regulatory scoping call for biotech and pharma startups — specialising in ATMP/CGT, biologics and small molecules

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.

Regulatory Affairs Consulting & ATMP /CGT Specialist

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Not certain about your regulatory pathway?

Minerva Regulatory Consulting provides specialist regulatory affairs support for advanced therapy medicinal products (ATMPs) and cell and gene therapies (CGTs), alongside broader biologics and small molecule programmes. We deliver both operational and strategic regulatory input across MHRA, EMA and FDA jurisdictions, from first clinical trial application through to marketing approval and post-approval lifecycle management.

Advanced therapies require regulatory expertise that goes beyond standard biologics frameworks. Minerva brings direct experience of the EMA’s ATMP classification process, PRIME designation strategy, CAT interactions and the specific CMC and non-clinical expectations that apply to gene therapy, cell therapy and tissue-engineered products.