Making clinical research crystal clear

Professional Medical Writing for EMA and FDA Submissions

Medical writing for regulatory submissions (e.g. FDA, EMA, Health Canada, CDSCO) and commercial purposes is a fundamental capability supporting clinical research. Scientifically accurate and high-quality documents are important to ensure clear communication of messages to diverse audiences and stakeholders. Krystelis has the necessary scientific and industry experience to deliver the full range of professional medical writing services to support pharma and biotechnology companies for their regulatory submissions. We can support ad hoc documents or deliver through a functional service provider engagement. Our writing team has:

• Extensive experience in providing writing services to the life sciences industry across therapeutic areas, using ICH-compliant templates
• The capability and capacity to support you across a wide range of document types, throughout all phases of clinical development and commercialisation
• Skillsets to prepare logically organised and succinct scientific content for regulatory submissions
• Data visualisation approaches that effectively convey key messages to diverse audiences – regulatory, business, and the public, including clinical study participants
• A deep understanding of the interdependencies of regulatory medical writing disciplines (e.g., CMC, pharmacology, pharmacokinetics, clinical, regulatory) from a strategic planning perspective and regulatory submissions
• Robust project management and facilitation skills to help negotiate with internal and external stakeholders. We always deliver to deadlines

Explore our Common Technical Document (CTD) writing services.