Medical Writing

Life sciences, where accuracy and clarity can be the difference between a successful clinical trial or approval process versus months or years of additional work. BioBoston Consulting offers a full range of Medical Writing support to assist you in the creation of these scientific documents and ensure your studies are clearly communicated to all stakeholders.

Reasons to Choose BioBoston Consulting for Medical Writing

Expert Medical Writers

Our team of medical writers are experienced in pharmaceutical, biotech and medical devices. We have the expertise to navigate the regulatory environment and distil complex scientific data into documents that are clear, concise, and compliant with requirements of regulatory agencies, clinicians or researchers.

Regulatory and Clinical Writing Proficiency

We provide medical writing support across all stages of product development, from preclinical to post-market. Our experience with regulatory submissions, clinical study reports, and scientific publications guarantees that your documents will be correct in terms of format and content, compliant with global standards.

Customized Solutions for Your Project

Our Medical Writing services can be strategically adapted to meet your projects objectives, targeted audience, and regulatory requirements. From clinical trial protocols to marketing authorization applications, we provide end-to-end writing support.

Regulatory Compliance Focus

Our team ensures that all medical documents are in full compliance with the regulatory standards of agencies such as the FDA, EMA, and ICH guidelines. Clarity, consistency and accuracy are our main objectives to increase the success of your regulatory submissions.

Timely Delivery and Collaboration

We work with your team to understand your timelines and deliverables of the project. Because of our collaborative process, you can expect your documents to be finalized and ready for submission on time with the highest standards of scientific and regulatory writing.

Some of our Medical Writing Services

Regulatory Submissions

Preparing regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, CTDs and 510(k) submissions) in accordance with global regulatory requirements.

Clinical Study Protocols and Reports

Writing detailed clinical trial protocols, clinical study reports (CSRs), and summaries that are aligned with GCP guidelines and tailored to support successful clinical trials and regulatory approvals.

Patient Safety Narratives

Preparing accurate and succinct patient safety narratives of adverse events in clinical trials in alignment with safety reporting requirements.

Investigator Brochures and Informed Customer Consent Forms

Developing investigator brochures and informed consent forms that are compliant with regulations while being understandable by participants.

Medical Marketing Materials

Development of promotional and marketing materials, product monographs and training documents that are accurate, regulatory compliant, and support your commercialization strategy.

Communicate with Confidence Through BioBoston Consulting’s Medical Writing Services

We take care of your Medical Writing needs and make sure your scientific documents are well-structured, accurate and fully aligned with regulatory guidelines. Let us help you communicate your data effectively and achieve success in your regulatory submissions, clinical trials, and product development efforts.

Contact Us Today

Schedule a consultation to learn how BioBoston Consulting can support your medical writing needs and enhance the quality of your scientific communications.