Medical Writing​

Avoid regulatory submission and approval delays by creating high-quality documents the first time round with the help of experienced medical writers. We provide clinical and regulatory medical writing services across all phases of development.​

Clinical Trial Protocols (CTP) and Amendments

Clinical Study Reports (CSR)

Investigator’s Brochures (IB)

Investigational Medicinal Product Dossiers (IMPD)

Investigational New Drugs (IND)

Common Technical Documents (CTD) Module 2 (including ISS and ISE)

Orphan Drug Designation Applications (ODD)

Paediatric Investigation Plans (PIP), Pediatric Study Plans (PSP)

Briefing Books

Development Safety Update Reports (DSUR)

Study Design and Synopsis Writing

Informed Consent Forms (ICF)

Clinical Development Plans (CDP)

Nonclinical Reports

Study design literature review, synopsis writing ​Clinical trial protocols & amendments Clinical study reports (CSR) Patient narratives

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Pre-trial

Investigational medicinal product dossiers (IMPD) Investigational new drugs (IND)

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Ongoing & Marketing Approval

Ongoing & Marketing Approval

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Post-trial

Clinical evaluation reports (CER) Common Technical Document (CTD) - Clinical summaries,

HR Functions

Non-clinical overview Integrated safety & efficacy summaries (ISS/ISE) Briefing books

Open Communication

Orphan designation applications Clinical and preclinical manuscripts

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