Expect the unexpected
Due to the increasing complexity of drug development and regulatory environment, the nonclinical and clinical plan, critical component, throughout the healthcare product development cycle require more and more customization and global vision. Nonclinical and clinical data are presented and interpreted in various regulatory interactions during the life cycle of a product.
At VCLS, our regulatory and nonclinical experts help design an optimal nonclinical development plan and prepare critical meetings with regulatory agencies adopting a benefit-risk approach to enable your product to move to the next phase.
Building solid foundations for your nonclinical and clinical development
- Design nonclinical, clinical development plan and draft nonclinical and clinical modules of INDs
- Provide nonclinical and clinical input for Investigator’s Brochure (IB)
- Design, draft and review clinical protocols, First-In-Human (FIH), Exploratory and Confirmatory studies
- Respond to Grounds for Non-Acceptance (GNA / Clinical Hold issues)
Learn more about our Clinical Submission and Operation capabilities.
Demonstrating significant benefit data
Draft/review nonclinical and clinical data and defend and review company position for:
- Orphan Drug Designation Scientific Advice procedures
- Accelerated programs, PRIME scheme, and Breakthrough Therapy Designation
- Paediatric Investigation Plan or Pediatric Study Plan, National and/or EMA Scientific Advice, EMA/HTA Scientific Advice and FDA Industry Meetings [INTERACT, Type A, Type B (pre-IND, EOP1/2, pre-NDA/BLA), Type C and Type D]
- INDs/CTA and MAA/NDA/BLA submissions
Learn more about our Regulatory Solutions.
It was a huge undertaking for rewriting completely module 2.7.3 and especially in such short timelines. ……
The D120 nonclinical responses you authored for this MAA submission was fantastic. I was really impressed by the work performed.
VP Biological Sciences, US-based Pharma in Oncology
Expertise 
