Technical & Medical 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