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