CMC Consulting & Regulatory Strategy

Ora’s in-house CMC (Chemistry, Manufacturing, and Control) and regulatory experts can help you navigate the development process, from consulting and submissions to turnkey clinical trial supply management.

Regulatory Strategy and Submissions

Ora works with you to provide a differentiated product by looking at all facets of your product and the current landscape.

  • MOA
  • Unmet medical needs
  • Competitive landscape and pipeline
  • Regulatory pathway
  • Overall likelihood of success

Clinical and Regulatory Strategy

Our Therapeutic Leaders and Chief Medical Officer will work with you to define the optimal study designs, endpoints, and patient populations to set your program up for success. We routinely facilitate discussions with global regulatory authorities at all phases of development, across all indications in ophthalmology. Our clinical, CMC and regulatory experts meet with international regulatory agencies on behalf of sponsors multiple times every month.

Comprehensive Regulatory Writing Services and Submissions

  • Briefing Documents for all types of global regulatory meetings
  • Investigational New Drug (IND), Investigational Medicinal Product Dossiers (IMPD), and Clinical Trial Applications (CTA), as well as maintenance of Amendments and Annual Reports
  • Investigational Device Exemption (IDE) Applications
  • New Drug Applications (NDA), Marketing Authorization Applications (MAA), and Generic Drug Applications (ANDAs)
  • 510(k) and PMA Applications for devices
  • Clinical Protocols
  • Investigator’s Brochures
  • Report on Previous Investigations (ROPI)
  • Clinical Study Reports (CSRs)
  • SAE Narratives

Medical Writing Services

  • Peer-reviewed manuscripts
  • Literature searches and reviews
  • Positioning white papers
  • Trade journal articles
  • Marketing materials