Medical Writing Services

Our starting point for clear, effective medical writing is a unique pool of talent sourced from former industry professionals.

By using the best medical writers, each with defined areas of therapeutic expertise, your project benefits from clear, compelling and effective documentation at every stage of your product's lifecycle.

Our regulatory and medical writing services include the planning, writing, formatting and compilation of:

Clinical study protocols
Clinical Study Reports (CSR) - Phases I - IV
Investigator brochures (IB) - de novo or annual updates
Summaries for online trial registries
Investigational Medicinal Product Dossiers (IMPD)
All components of the Common Technical Document (CTD) CMC and non-clinical regulatory documents
Clinical expert statements and case narratives
Annual Safety Reports (ASRs) and Periodic Safety Update Reports (PSURs)
Signal evaluation and issue workups
Benefit-Risk assessments
Risk Management Plans

We also provide advice and support for:

Pharmacovigilance system and process reviews
Resolution and response to safety issues (e.g. Urgent Safety Restrictions)
Weekly and bespoke literature searching
Preparation of medical writing Standard Operating Procedures (SOPs)

Combining high level strategic insight with an eye for detail - we deliver compelling documents with the highest levels of clarity, accuracy and readability.

Read an example case study

To find out more, download our medical writing brochure. Or call us today on +44(0)1403 320280.

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Spectrum Regulatory Solutions, Fraser House, 14 Carfax, Horsham, West Sussex RH12 1DZ regulate@spectrumrs.com. Spectrumrs.com is the trading name of Spectrum Regulatory Solutions Ltd. Spectrum Regulatory Solutions is a limited company registered in England and Wales with company number 5331222. Registered office: St James's House, 8 Overcliffe, Gravesend, Kent DA11 0HJ. VAT registration no: 818283318