Scientifically rigorous, reviewer-friendly medical writing to help life science teams deliver clear, consistent documentation across clinical development and regulatory milestones.
Scientifically educated writers (PhD/MS backgrounds) producing clear, concise, compliant, readable documents.
Integrated collaboration with cross-functional internal experts (clinical, regulatory, non-clinical, and CMC) and sponsor experts.
Dedicated lead writer + structured planning to protect timelines.
GCP-trained and rigorous quality standards with an embedded thorough review and quality control process.
Startups, biotech and pharma requiring clarity, consistency and cross-functional alignment in documentation.
High‑quality, accurate, reviewer-friendly document creation supporting clinical development and regulatory submissions.
Scope & submission context
Source review & content planning
Collaborative authoring and review
Review-cycle management
QC & submission readiness
Challenge: Parallel clinical reporting + IND documentation
Approach: Message map, two-level QC, dedicated writer
Outcome: Successful pre-IND meeting followed by IND application in accordance with the specified timelines
We provide comprehensive medical writing support across the full clinical development pathway. This includes trial outlines, protocols and amendments, , investigator’s brochures (IBs), participant information leaflet – informed consent forms (PIS-ICFs), clinical study reports (CSRs), narratives, lay summaries, abbreviated CSRs, and scientific publication of trial results., Scientific advice briefing packages, CTD clinical modules and other regulatory documents can be developed for you for regulatory agency interactions.
Our writing approach is grounded in scientific excellence and regulatory alignment. We use guidance-aligned templates, standardised terminology, clear data traceability, and a multilayer QC process to ensure accuracy. Cross-document consistency checks maintain alignment across protocols, PIS-ICFs, IBs, and CSRs, but also across CSRs and briefing packages or CTDs. Every document is reviewed through a structured QA process to ensure it meets regulatory expectations.
Yes. We can embed a dedicated medical writer into your programme to provide continuity, deep understanding of your asset, and consistent storyline development. This model reduces onboarding burden, accelerates drafting, and helps maintain alignment across multiple deliverables developed in parallel.
We use a structured review framework that streamlines collaboration across the team and with the sponsor. This includes clear review timelines, consolidated review comment logs, tracked adjudication of relevant comments, proactive clarification with SMEs before revisions are made, and comment resolution meetings, when required. Strong version control and decision tracking ensure documents move through each iteration smoothly and efficiently.
Yes. We prepare full scientific advice packages, including meeting requests, briefing books, and written responses to authority questions.
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