Pharmaceutical programmes require documents that withstand protocol governance, health-authority scrutiny, and journal review. Assignments focus on clinical and non-clinical deliverables that read as a single voice across modules and publications, with explicit links from narrative to tables, listings, and figures, and assumptions stated so multidisciplinary reviewers can verify every step.
Clinical documentation includes protocol language and statistical analysis plan wording aligned to ICH E6(R2) and E9 (including estimands), Investigator’s Brochures that present mechanism, pharmacology, and safety with preserved change histories, and Clinical Study Reports to ICH E3 with consistent numbers, units, and effect directions across text and tables. Integrated analyses are prepared with future filings in mind: Module 2.5 Clinical Overview, Module 2.7 Clinical Summary, and, where applicable, ISS and ISE are scoped early so selection logic, terminology, and cross-references remain stable through the lifecycle.
Authority-interaction materials are written to make meetings productive and responses crisp. Scientific-advice and pre-submission briefing books state the question, set out options and evidence, and flag uncertainty. Information-request responses map point-by-point with tracked revisions and a citation pack for rapid verification. Labeling language aligns to EU SmPC/PL with QRD templates and to FDA PLR formatting, with regional variations tracked so local labels remain consistent with the Core Data Sheet and risk-management materials.
Publication support turns programme data into manuscripts, reviews, and conference materials that hold up to editorial and statistical review. Reporting follows venue rules and accepted standards, including CONSORT for trials, PRISMA for reviews, and ICMJE requirements for authorship, disclosures, and data-sharing statements. Figures and tables are built from verifiable sources; graphical abstracts and plain-language summaries are provided when appropriate. Response-to-reviewers documents are drafted with point-by-point mapping and reconciled numbers.
Safety and lifecycle writing applies the same discipline. Risk Management Plans present identified and potential risks with rationale for minimisation measures and post-authorisation commitments. Development Safety Update Reports and periodic safety materials apply consistent definitions, trace sources, and make safety signals and mitigations easy to follow. For EU CTR, lay summaries of clinical-trial results are drafted in plain language while preserving scientific accuracy.
Operational delivery is predictable. Draft one lands on the scheduled date with tracked changes and a comment log that explains decisions and references. One focused revision round is included to close open questions. Handover includes submission files, editable vector figures, and the managed bibliography, prepared to slot into eCTD publishing workflows and document-control systems. Confidential material is handled under NDA with encrypted transfer, named-user access, and retention limited to the period specified in the statement of work.
Assignments are executed in English for organisations across Europe and beyond. Contracting and invoicing can be arranged in CHF, EUR, NOK, or DKK.
To scope a pharma engagement, share the regulatory goal, target authorities, dossier components or manuscripts in view, key study inputs, and timeline. A statement of work will define method, deliverables, milestones, and price as fixed or capped.