Medical & Scientific Writing
Regulatory document authoring, clinical study reports, and submission-ready deliverables crafted by experienced medical writers with deep therapeutic knowledge. Our writing team translates complex clinical and scientific data into clear, compliant documents that meet the expectations of health authorities worldwide.
Documents That Advance Your Programme
MTK Pharma Services provides end-to-end medical writing support for every stage of clinical development. Our writers hold advanced degrees in life sciences and bring years of hands-on experience authoring regulatory documents across multiple therapeutic areas and submission types. Each deliverable is structured to tell a coherent scientific story that satisfies regulatory requirements and supports your development objectives.
From early-phase investigator brochures and clinical study protocols through pivotal CSRs and marketing authorisation dossiers, we maintain a consistent quality standard rooted in ICH E3 guidance, agency-specific formatting expectations, and your own organisational style conventions. The result is submission-ready documentation that withstands regulatory review without costly revision cycles.
Comprehensive Medical Writing Services
Six specialised writing disciplines covering the full spectrum of clinical and regulatory documentation — from individual study deliverables through integrated submission packages and peer-reviewed publications.
Clinical Study Reports (CSRs)
Full ICH E3-compliant CSR authoring from shell development through final quality review, presenting your study results with scientific clarity and regulatory precision.
- ICH E3-structured report authoring
- Efficacy and safety results narratives
- Synopsis and abbreviated CSR formats
- Integrated tables, figures, and listings
Investigator Brochures
Comprehensive IB development and annual updates that synthesise non-clinical and clinical data into a clear reference document for site investigators.
- Initial IB development and structuring
- Annual and ad hoc IB updates
- Non-clinical and clinical data integration
- Risk-benefit assessment summaries
Regulatory Submission Documents
Authoring of CTD Module 2 summaries, briefing documents, and health authority response packages that present your data in a compelling regulatory narrative.
- CTD Module 2.5 and 2.7 summaries
- Briefing documents for agency meetings
- Health authority response narratives
- Orphan drug designation applications
Patient Narratives
Concise, medically accurate patient narratives for serious adverse events, deaths, and discontinuations that satisfy ICH E3 appendix requirements.
- SAE and death case narratives
- Discontinuation summaries
- Structured narrative templates
- Medical review and sign-off coordination
Safety Reports & PSURs
Periodic safety update reports, development safety update reports, and risk evaluation documents authored to current ICH E2E and agency-specific standards.
- PBRER / PSUR authoring
- DSUR preparation and updates
- Risk management plan narratives
- Addendum and line listing coordination
Publication Support
Manuscript development, congress abstracts, and poster preparation for peer-reviewed journals and scientific conferences, following ICMJE and GPP3 guidelines.
- Peer-reviewed manuscript drafting
- Congress abstract and poster writing
- ICMJE and GPP3 compliance
- Journal submission coordination
Regulatory & Clinical Document Types
Our medical writers have authored thousands of regulatory and clinical documents across every stage of pharmaceutical development. Below are the key document categories we deliver routinely for our sponsors.
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IND / NDA Narratives
Investigational new drug and new drug application narratives that present clinical evidence with the structure and depth health authorities expect for regulatory decision-making.
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Protocols & Informed Consent
Study protocols authored in collaboration with clinical and medical teams, accompanied by clear, patient-friendly informed consent documents that meet local ethics requirements.
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Investigator Brochures & CSRs
Comprehensive investigator brochures and ICH E3-compliant clinical study reports that synthesise non-clinical, clinical, and statistical data into a cohesive regulatory narrative.
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PBRERs & Safety Documents
Periodic benefit-risk evaluation reports, development safety update reports, and risk management plan documents authored to ICH E2E standards with current safety data integration.
Why Choose MTK for Medical Writing
Regulatory documents are the voice of your clinical programme. Choosing the right writing partner ensures that voice is clear, compliant, and compelling at every stage of the development lifecycle.
Scientific Expertise
Our writers hold advanced degrees in biomedical sciences and bring hands-on experience across oncology, immunology, CNS, cardiovascular, and rare disease programmes.
Rigorous Quality Control
Every document undergoes independent QC review, editorial checking, and medical accuracy verification before delivery, ensuring consistency and compliance throughout.
Multi-Agency Experience
Documents authored to satisfy FDA, EMA, MHRA, PMDA, and TGA requirements simultaneously, enabling efficient global submissions without duplicated writing effort.
Cross-Functional Integration
Tight coordination with our biostatistics, data management, and regulatory affairs teams ensures that statistical outputs, data listings, and submission strategy inform every document.
Discuss Your Writing Needs
Whether you need a single CSR, an ongoing functional writing team, or a complete submission document package, our medical writers are ready to deliver. Contact us to explore how MTK can provide the regulatory writing expertise your programme requires.