Medical and regulatory writing for critical projects
From clinical trial protocols to post-marketing safety reports, SGS medical writers transform data into precise, regulatory-ready documents. With decades of expertise and a readily available team, we help pharma and biotech companies deliver on time, every time.
Experience that runs deep
We staff projects with high-qualified medical writers (scientific master or PhD) with deep therapeutic knowledge and dossier familiarity.
Trusted for high-complexity projects
When documentation is fragmented, technically demanding or high-stakes, our team thrives under pressure and brings clarity where others stall.
Regulatory know-how
Based in Belgium, we know the ins and outs of local, EU and global ICH regulatory expectations.
Full project ownership
We manage the entire writing flow: from briefing to chasing input to final QC. So your teams can stay focused on strategy.
When you need to be sure
Trusted partner for high-stakes writing
Work with readily available experts who bring clarity, compliance and peace of mind to your projects.
Integrated teamwork
With outsourcing or insourcing, we go beyond execution — we work with you to collaborate, align and deliver impact.
Ready when you are
Our experienced writers are available for immediate deployment to support your clinical, regulatory and scientific communication needs.
Glenn Borgmans
Business Development Manager
Writers, ready to go
Kristel Gysemans
At SGS since 2007
Degree: PhD in Engineering, KULeuven
Christoph Tombeur
At SGS since 2013
Degree: Master in Biochemistry, University of Antwerp
Julie Tobback
At SGS since 2012
Degree: PhD in Biochemistry and Biotechnology, KULeuven
With more than a dozen experienced medical writers available, SGS offers immediate support to pharma and biotech teams facing resource gaps, backlogs or urgent submissions. You choose the model – on-site, project-based, or long-term – and we provide the right experts to fit seamlessly into your workflow.
Pharmaceutical company
Client
When there’s an SGS writer on the team, it’s a relief. They bring clarity and stability where it’s most needed.
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Writing during drug development and clinical studies
- Clinical Trial Protocols (CTP)
- Investigator’s Brochures (IB)
- Clinical Study Reports (CSR), including subject-level narratives & lay summaries
- Virology/microbiology/biomarker reports
- Informed Consent Forms (ICF), including Patient Information Sheet (PIS)
- Investigational Medicinal Product Dossiers (IMPD)
- Pediatric Investigation/Study Plans (PIP/PSP)
- Briefing books/briefing documents for different purposes
- End of phase 1 or 2, phase 3 trial design and endpoints (for EMA, FDA, WHO, other HAs)
- PRIME Applications (EMA) and Breakthrough Designation (FDA)
- Orphan drug designations (ODD) (EMA)
- Responses to HA questions on briefing documents
- Development Safety Update Reports (DSURs), IND Annual Reports and Individual Case Safety Reports (ICSRs)
- Clinical Development Plan (CDP)
- Requests for information/responses to HA/EC/IRB questions
Writing during drug marketing authorization applications
- Clinical Efficacy & Safety Summaries (SCE/SCS) and Clinical Overviews (COs)
- Summary of biopharmaceutic studies and associated analytical methods, summary of clinical pharmacology studies, supporting summaries for microbiology, virology, ...
- Labelling documents: Company Core Data Sheets (CCDS), Summary of Products Characteristics (SmPC), US Patient Information (USPI)
- EU and Core Risk Management Plan (RMP)
Other (post-marketing) writing activities
- Periodic Safety Update Reports (PSUR) and Periodic Benefit Risk Evaluation Reports (PBRER)
- Scientific publications, abstracts, posters and presentations
- Meeting minutes for various meetings including Advisory Boards, IDMC, DSMB