Regulatory Strategy & Submissions

We provide international regulatory strategy, representation, writing and electronic submissions throughout the entire product development lifecycle.

Clinical and Regulatory Strategy

    • Our Therapeutic Area Heads 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. On average, our clinical, CMC and regulatory experts are meeting with international regulatory agencies on behalf of sponsors 2-3 times each month.

Comprehensive Regulatory Writing Services and Submissions

  • Briefing Documents for all types of regulatory meetings, US and OUS
  • Investigational New Drug (IND), Investigational Medicinal Product Dossiers (IMPD) and Clinical Trial Applications (CTA) and 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