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

Technical & Medical Writing Service

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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 & medical writing support to strengthen your documentation?

High-quality regulatory documentation is fundamental to a successful submission. Minerva provides expert technical writing and document review across the full range of CMC and regulatory documentation — with particular depth in the specialist documentation required for ATMP, cell and gene therapy programmes.

Every document is authored to the standard expected by MHRA, EMA and FDA reviewers, with scientific rigour and regulatory precision built in from the first draft.