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Expertise

Nonclinical and Clinical

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 ad 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, FIH, Exploratory and Confirmatory
  • Respond to Grounds for Non-Acceptance (GNA)

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 pre-IND meeting
  • MAA, NDA, BLA submissions

Learn more about our Regulatory Solutions.

VCLS Expertise