Non-clinical Input Into Other Technical Documents
Our team has significant experience of undertaking nonclinical aspects of other documents required in the development process:
Investigator’s Brochure
Investigational Medical Product Dossier
Briefing Packages
Special Protocol Assessment
Risk Management Plan
Paediatric Investigation Plans (PIP)
Reference in other regular reports such as DSURs
Please contact us for support and questions in any non-clinical safety toxicology and CMC related to products and medical devices.