Medical Writing and Regulatory Submissions

 

Our Medical Writing team provides accurate documentation compliant with ICH guidelines and FDA regulations.  Our highly qualified medical writing staff will work closely with your team to produce precise documentation for a wide variety of drug therapeutic areas and medical device categories.  Our medical writers have written over 100 manuscripts that were published in highly acclaimed peer reviewed journals.

Our medical writers have scientific degrees and have experiences in many therapeutic areas.  Our medical writing team averages over 20 years of experience. And no matter what template, writing style or electronic document management system you follow, they will write and finalize documents within your specifications.

Our medical writing and regulatory submission services include:

  • Drug submissions: IND, NDA, CTD, ANDAs
  • Medical Device submissions: 510(k), IDE, PMA
  • Investigator’s Brochures and Briefing Documents
  • Clinical Trial Documentation: Protocols, Informed Consent Forms, and ICH-compliant Clinical Study Reports
  • Medical & scientific literature review manuscripts
  • Patient narratives
  • Quarterly and annual report updates
  • White papers

OUR RATES ARE MUCH LOWER THAN LARGE CRO RATES!

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“Their work has been of a high standard and delivered on-time and on-budget.” – Kenneth Ibbotson, PhD, Kendle International Inc., Cincinnati, Ohio, USA