Regulatory Consulting

Our regular interfaces with the FDA enable us to prepare informed clinical-regulatory strategies for our clients.

For over 30 years, Ora has scheduled regular interfaces with the FDA, enabling us to prepare informed clinical-regulatory strategies for our clients. We provide our clients with:

  • Innovative and efficient methods for looking at therapeutics, while maintaining focus on the ultimate objective of timely marketing approval
  • Close interaction with divisions at the FDA for drugs, biologics, and devices
  • Deep international regulatory agency experience, including PMDA, EMA, B-Pharm, and DCGI

The Ora team frequently accompanies clients to the FDA to present plans and data. We also work with our clients in the development of:

  • Pre-IND strategies
  • Preparation and submission of pre-IND packages
  • Investigational New Drug Applications (INDs)
  • New Drug Applications (NDAs)
    We can prepare the entire document, or prepare specific sections as requested by our clients
  • 510(k) Applications
  • Investigational Device Exemption (IDE) applications.