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.