Biotechnology programmes move quickly and change shape as data arrive. Documents need a single authorial voice, precise methods, and calibrated language that can evolve without losing consistency across protocols, regulatory packages, publications, and investor materials. Support focuses on early- to mid-stage development where clear narrative, disciplined evidence handling, and predictable delivery help teams make decisions and meet milestones.
Programme documents include protocol language and statistical text aligned to ICH E6(R2) and E9, Investigator’s Brochures that integrate mechanism, pharmacology, and emerging safety with preserved change histories, and Clinical Study Reports to ICH E3 that reconcile numbers, units, and effect directions between narrative and tables. When future filings are likely, selection logic and terminology are stabilised early so Module 2 clinical overviews, clinical summaries, and any integrated analyses remain coherent as the dataset grows. For devices or diagnostics within a platform, clinical/performance evaluation narratives can be prepared to MDR/IVDR expectations or to FDA routes such as 510(k), De Novo, or PMA.
Translational and mechanism summaries bridge discovery and clinic. Evidence from models, pharmacology, and early human data is organised so reviewers can see plausibility and limits of inference. Targeted or systematic reviews follow protocolled steps; search strategies, selection flow, and bias assessment are archived and reproducible. Where pooling is justified, models and heterogeneity checks are stated explicitly, and conclusions are bounded by the strength of evidence. Safety language is harmonised, with consistent coding and definitions across documents so signals track cleanly over time.
External communication supports financing and partnerships without overstating certainty. White papers, board and investment-committee briefs, and partner decks translate technical results into options and trade-offs for time-constrained readers while maintaining scientific precision. Public-facing statements align to regulatory positions and disclosure rules to avoid selective release; forward-looking statements are separated from empirical findings and labelled appropriately.
Operational delivery is predictable. Draft one arrives on the scheduled date with tracked changes and a comment log explaining assumptions and references. One focused revision round is included to close open questions. Handover includes submission files, editable vector figures, and a managed bibliography prepared to slot into eCTD publishing and internal document control. 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.