We take care to provide our customers with high quality services, personalized for their unique needs.

We provide a variety of services, including:

Global Drug Development

  • Clinical study protocol
  • Investigator’s brochure
  • Informed consent
  • Protocol amendments
  • Clinical study report
  • Investigator list, abbreviated CVs
  • Patient narratives
  • IMPD documents
  • CTD documents
  • Briefing documents
  • Integrated summary of safety/efficacy
  • Literature summaries
  • Clinical trial registries
  • Preparation of regulatory document packages
  • Review of documents prior to submission

 

Global Medical Affairs

  • IND lifecycle management
  • IND and NDA annual report
  • Aggregate reports
  • Periodic safety update report (PSUR)
  • Literature review

 

Strategic Drug Development

  • Development strategies
  • Clinical development plan
  • New product acquisition support
  • Due diligence of potential products

 

For further information or questions concerning our services, please contact us directly by phone +1-978-394-9722 or e-mail info@qarapharmasolutions.com. Our clinical and regulatory experts will assist you in finding the best solution for your current needs.