A successful ophthalmic program starts with an informed, clear, compliant Regulatory Strategy. Oculos understands the importance of this Strategy as a key element to our clients’ success. Our years of experience (as Sponsors and Service Providers) developing, authoring and presenting regulatory strategy/documents to regulators gives our clients confidence that the plan will be accepted by regulators across the globe.
Examples of the services we provide in this space:
- Preparation of FDA-briefing packages
- FDA-meeting representation
- Authoring and submission of INDs/IDEs
- Prepare and submission of NDAs/BLAs (eCTD)
- Authoring of clinical protocols
- Preparation and submission of materials for IRBs
- Write and file Orphan Drug product designation
