Regulatory communication delivers clear, consistent dossiers and briefing materials that align with authority expectations and withstand detailed review. Work covers clinical and non-clinical summaries, overviews, briefing packages, response documents, and submission-ready language for labeling and risk materials. Documents are written in English for international use and calibrated for authorities such as EMA, FDA, MHRA, and Swissmedic, with structures that map cleanly to eCTD modules and company templates. Labeling is aligned to SmPC/PL and QRD in the EU and to FDA PLR formatting in the US, with regional variations tracked.
Clinical and non-clinical summaries follow ICH conventions so reviewers can navigate and verify claims efficiently. Module 2.5 Clinical Overview and Module 2.7 Clinical Summary are written to integrate results across studies with explicit links to tables, listings, and figures. Non-clinical components (Modules 2.4 and 2.6) align findings to the human safety narrative. Where applicable, integrated analyses such as ISS and ISE are referenced with clear study selection logic, traceable inclusion/exclusion rules, and consistent terminology across sections. For MDR/IVDR and FDA device routes, materials support clinical/performance evaluation and submission narratives (e.g., 510(k)/De Novo/PMA) with consistent evidence mapping.
Operational documents are drafted to reduce ambiguity and pre-empt common queries. Protocol and statistical analysis plan language is shaped to E6(R2) expectations, with endpoints, estimands, and analysis populations described consistently with E9 and addenda. Investigator’s Brochures present mechanism, pharmacology, and safety in a reviewer-friendly flow with change histories preserved. Clinical Study Reports adhere to ICH E3, with narrative-to-table cross-references and consistency checks on numbers, units, and effect directions.
Authority interaction materials are written to make meetings productive and responses crisp. Pre-submission and scientific-advice briefing books state the question, options, and evidence with transparent assumptions. Responses to information requests and “Q-lists” are prepared with point-by-point mapping, tracked revisions, and a citation pack that allows rapid verification. When labeling is in scope, Core Data Sheet and local label language is aligned to the evidence and to risk-management requirements.
Safety and lifecycle documents are handled with the same discipline. Risk Management Plans present identified and potential risks with rationale for minimisation measures, linked to post-authorisation commitments. Periodic safety materials and development safety updates apply consistent definitions and trace sources so safety signals and mitigations are easy to follow. For EU CTR, lay summaries of clinical trial results are drafted in plain language while preserving scientific accuracy.
Quality controls are embedded from scoping to sign-off. Claims match the strength of evidence, uncertainty is declared when material to decisions, acronyms are controlled, and change logs record edits across review rounds. Numbering, terminology, and cross-references are harmonised across modules so the dossier reads as a single voice. All citations are validated against source metadata. Confidential data handling follows GDPR with encrypted file exchange, named-user access, and retention limited to the period specified in the statement of work.
Delivery is predictable. Draft one lands on the scheduled date with tracked changes and a comment log explaining key decisions and references. One focused revision round is included to close open questions and finalise the document. Handover includes submission files, editable figures, and the managed bibliography, prepared to slot into eCTD publishing workflows. Assignments are executed in English for organisations across Europe and beyond, with contracting and invoicing available in CHF, EUR, NOK, or DKK.
For scoping, share the regulatory goal, the target authorities, the dossier components required, key study inputs, deadline, and any authority feedback received to date. A written statement of work will set the method, deliverables, schedule, and pricing as fixed or capped, with milestones aligned to internal governance.