Medical writing, quality and transparency services
Expert support that reduces risk, accelerates timelines and enhances submission quality
Sponsors face increasing pressure to deliver high quality regulatory documents under tight timelines, with shifting priorities, variable internal capacity and rising expectations for transparency. These pressures create risks that can delay development, invite regulatory questions or compromise submission quality.
ICON helps sponsors reduce risk, accelerate timelines and meet global regulatory expectations. Our medical writers, editors and clinical trial transparency specialists deliver high quality documents across the product life cycle, supported by rigorous quality control.
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400+
highly experienced international professionals -
5,500+
documents per year -
All major therapeutic areas
The ICON solution
We focus on keeping programmes moving with clarity and precision.
Early planning and agile teams keep timelines steady
Coordinated global writers meet regional expectations
Editorial review elevates clarity and reduces rework
Flexible resourcing adapts to any delivery model
Clear disclosure planning supports transparent reporting
Plain language summaries and strong anonymisation improve accessibility
A comprehensive range of services
Our medical writing, quality and transparency team provides end‑to‑end support, ensuring clear, accurate and compliant content at every stage of development.
Clinical documents
Protocol synopses, protocols, amendments, Clinical Study Reports in ICH E3 and PASS formats, bridging and ethnic sensitivity reports, narratives, redactions, plain language summaries and investigator brochures are produced with clarity and scientific accuracy.
Marketing applications
Global submissions are supported through preparation of INDs, NDAs, MAAs, BLAs, CTD content, Module 2 summaries, integrated safety and efficacy summaries, expedited pathway applications, conditional authorisations, agency responses and lifecycle updates. Clinical trial applications, voluntary harmonisation procedure documents, adaptive licensing materials and PMDA and NMPA submissions are also developed.
Regulatory
Investigational medicinal product dossiers, risk management plans, assessment aids, paediatric plans, briefing packages, scientific advice materials, expert overviews, NDA annual reports and CCDS or label updates are prepared with consistency and regulatory alignment.
Other documents
Development plans, journal manuscripts, abstracts, posters, physician and patient texts, white papers, literature reviews, slide presentations, ad hoc consultancy materials and informed consent forms are created to meet clinical, regulatory and scientific communication needs.
Technology enabled delivery
An intelligent approach to document authoring:
ICON leverages a secure AI tool for automation and content improvement for CSR generation, patient narrative generation, and CSR plain language summary creation. This ensures consistency across documents and accelerates the CSR development cycle, while significantly reducing manual effort and time.
We utilise a range of other digital tools to improve speed, accuracy and collaboration throughout document development, including EndNote, Sage based templates, PerfectIt, PleaseReview, and other specialised platforms.
Support on your terms
ICON’s medical writing team supports pharmaceutical, biotech and medical device organisations of all sizes and across all therapeutic areas. Services can be delivered as consulting, standalone, FSP, blended or full service and across all therapeutic areas.
Streamlining dossier preparation
Medical writing professionals play a pivotal role in preparing regulatory submission dossiers. Through years of experience, our experts have developed effective strategies to streamline the submission process and implement best practices that ensure high-quality, compliant documentation.