Clinical and Regulatory Documents
We provide clinical and regulatory writing services throughout the product lifecycle,
from preclinical through phases I–IV and marketing support.
Our experience of writing and editorial provision includes:

Investigator brochures
Study protocols
Patient narratives
Responses to regulatory authority queries
CTD format for NDAs and MAAsCommon technical document (CTD) format for new drug applications (NDAs) and marketing authorisation applications (MAAs)
Safety reports Including periodic benefit-risk evaluation reports (PBRERs)