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Clear, compliant, and always on time

Medical Writing
We offer premium medical writing services across all therapeutic areas and fields within biomedical fields. Our team of doctorate-level experts ensures precise, compliant, and compelling documents that drive your clinical and regulatory success.

Clinical Study Writing

Accurate, well-structured clinical study documents are essential for regulatory approval and successful study execution.
As part of our medical writing services, our expert writers ensure your protocols and reports are clear, compliant, and tailored to meet regulatory requirements.

Study Protocols & Reports

Submission-ready, ICH-compliant protocols and reports for all study phases. Ensure your study documents meet regulatory expectations with our expert regulatory writing services and guidance.

Patient Narratives

Clear and concise summaries tailored to regulatory requirements. We help you communicate patient data effectively and compliantly.

Regulatory &
Development Documents

Navigating regulatory requirements can be complex, but with Bioforum’s expertise and comprehensive regulatory writing services, your documentation will be meticulously prepared to meet FDA, EMA, and ICH standards, ensuring smooth submission and approval.

Briefing Packages

Expertly crafted documents for regulatory meetings. Make a strong impression with well-structured, compelling content.

Investigator’s Brochures

Comprehensive study and product information. Keep investigators informed with high-quality, detailed brochures.

Data Safety Update Reports (DSURs)

Ensure compliance and safety monitoring. Maintain regulatory compliance and demonstrate patient safety effectively.

Common Technical Document (CTD) Summaries

Structured summaries for regulatory submissions. Get your data submission-ready with precise, high-quality documentation.

Integrated Summaries (ISS/ISE)

Clear and concise safety and efficacy reports. Strengthen your regulatory submissions with our expert medical writing services.

Download Datasheet

Medical Communication

Effective communication is key to scientific success.

Our medical writing services team helps you present your findings clearly and professionally, whether for journal publication, conferences, or stakeholder engagement.

Journal Articles
Journal Articles
Writing and editing support, from de novo drafting to final submission. As a trusted medical writing agency, we help you share your research effectively with expertly crafted articles.
Medical
Presentations & Posters
Medical
Presentations & Posters
Professional slide decks, abstracts, and poster content. Among leading medical writing companies, our team delivers impactful presentations with clear, concise materials.
Publication Strategy
Publication Strategy
Assistance with journal selection and submission planning. Our expertise in medical article writing helps you maximize publication success through strategic guidance and precision-driven support.

Quality Control

Precision and compliance are non-negotiable in regulatory submissions. Bioforum provides rigorous quality control as part of our regulatory writing services, ensuring your documents meet the highest industry standards — setting us apart from other regulatory writing companies worldwide.

QC for Regulatory Documents

Thorough quality checks ensure accuracy and compliance. Avoid costly errors with our rigorous quality control processes designed specifically for regulatory medical writing documents.

Training Services

Empower your team with the knowledge and skills to excel in regulatory medical writing and documentation. Our tailored training programs provide hands-on experience and best practices to enhance expertise.

Regulatory & Clinical Writing Training

Tailored workshops for researchers and industry professionals. Strengthen your team’s capabilities in clinical and regulatory writing services with customized training.

Protocol Development Courses

Hands-on guidance on writing study protocols. Our medical writing agency provides expert-led training to strengthen your protocol development process and ensure regulatory excellence.

Why Choose Bioforum?

Doctorate-Level Experts
Highly experienced writers across diverse therapeutic areas. Work with professionals from one of the leading medical writing companies who understand your industry’s unique challenges.
End-to-End Support
From study protocols to final regulatory submissions. Simplify your clinical trial documentation with our full-spectrum medical writing services.
Regulatory Excellence
Proven success in FDA and EMA submissions. Trust a team with a track record of regulatory approval success.
Medical Writing Services – Frequently Asked Questions

Our medical writers have experience in a wide variety of therapeutic areas including Neurology, Oncology, Infectious Diseases, Immunology, Genetics, Computational Biology/Bioinformatics, Pharmacology, Hematology, Drug Development, (AI-based) Medical Devices and Molecular Diagnostics.

The amount of time to complete a writing project varies significantly between projects. The complexity of the studies and the development program are the primary factors in determining the time to completion of a writing project. As one of the leading regulatory writing companies, Bioforum ensures efficient timelines by assigning two writers per project and maintaining clear communication throughout the process. A few additional factors include the amount of literature searching required (i.e., if the Sponsor can provide a literature collection, this helps accelerate the writing process), the clarity of messaging, and the availability of reviewers to provide input on drafts. We discuss timelines during the kickoff meeting to increase writer availability and enable concurrent work where applicable.

We prepare a unique proposal for each project. As a professional medical writing agency, our unit of pricing is based on hours of work, and our standard process includes a shell document, three full drafts, quality checking, and publishing. The effort estimation includes internal review and oversight by a team leader. We also offer a timed contract model, in which a writer is fully dedicated to a client and can work on multiple projects. This model is available on a full- or half-time employee (FTE) basis for 3-, 6-, or 12-month contracts and includes support from MW team leaders.

Learn more about our services