Expect the unexpected.
Due to the increasing complexity of drug development and regulatory requirement, the nonclinical and clinical plan becomes a more critical component throughout the healthcare product development cycle. Nonclinical and clinical data are presented in various regulatory documents during the life cycle of a product.
At VCLS, our regulatory and nonclinical experts can 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 clinical development
- Design nonclinical, clinical development plan and draft nonclinical and clinical modules of INDs
- Provide clinical input for Investigator’s Brochure (IB)
- Design, draft and review on FIH synopsis, Phase 2 or Phase 3 study synopsis
- Respond to Grounds for Non-Acceptance (GNA)
Learn more about our Clinical Submission and Operation capabilities.
Demonstrating significant benefit data and meeting regulatory agencies’ expectations
- Draft and review nonclinical and clinical data on Orphan Drug Designation (ODD)
- Draft and review nonclinical and clinical data on accelerated programs, such as European PRIME scheme and Breakthrough Therapy Designation (BTD) in the US
- Paediatric Investigation Plan (PIP) or Pediatric Study Plan (PSP)
- Defend and review company position during National and/or EMA Scientific Advice, EMA/HTA Scientific Advice and pre-IND meeting
- Draft, review nonclinical and clinical information in MAA, NDA, BLA dossier
Learn more about our Regulatory Solutions.