Document Writing (preparation of regulatory, commercial documents and publications) 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 can support all your document writing needs, whether it is for single documents or through a functional service provider engagement. Our writing team has:

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