Regulatory Writing

Our Regulatory Writing Team is highly accomplished in a wide array of regulatory document preparation.

Integrated Approach

At Ora, the Regulatory Writing group is involved in all phases of our client’s drug development process. 

Ora provides clients with a comprehensive ophthalmic drug development program.  Regulatory writers routinely participate, along with Ora management and Ora’s clinical groups, in early discussions with potential clients.  The Regulatory Writing group then works with the Ora clinical group and the Sponsor throughout the course of the drug development project, preparing all necessary documents for submission to the U.S. Food & Drug Administration (FDA) and to the client.  Regulatory writers support Ora’s clinical groups with literature searches on specific compounds, potential new drug targets or drug mechanisms of action so that they are well informed regarding development decisions.  Often this material is used for trade journal or peer-review journal publications in an effort to heighten industry awareness of key issues and growing trends.  

Comprehensive Regulatory Writing Services

The Regulatory Writing group provides a full range of writing services, either in support of a client’s drug development program, or as a stand-alone service.  Ora’s Regulatory Writing group routinely prepares the following documents:  

  • Briefing documents for FDA meetings
  • Investigational New Drug (IND) applications
  • Clinical protocols
  • Investigator’s Brochures
  • Clinical study reports
  • Patient safety narratives
  • Drug, device and biologic marketing application components
  • IND annual reports
  • Pre-clinical and scientific reports
  • Manuscripts for journal submission
  • Focused literature reviews and reports

Ora’s Regulatory Writing group maintains high standards for document clarity and quality. Document preparation proceeds with regular consultation to ensure that project needs are incorporated and that client preferences for presentation are followed.  All documents are reviewed internally before being released to the client or to the FDA.  All documents are prepared on time and are scientifically sound and fully compliant with any applicable regulatory guidelines.