Carexa Inc.

2536 Ridgeside Lane,
Oakville, ON L6L 6W3 Canada
(905) 338-0909
fax: (905) 338-1010
info@carexa.com

 

About Us

Services

 

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Our Services

Strategy & Planning

  • Development of regulatory strategies
  • Assessment of existing regulatory strategies and timelines and provide recommendations for change
  • Preparation of project plans for drug development and associated regulatory activities

Regulatory Submission Preparation

  • Applications to conduct clinical research (IND, CTA)
  • Applications to market a product (CTD, eCTD, NDA/BLA, NDS, MAA)
  • Up-dating and maintenance of regulatory files, including responses to information requests from regulatory agencies

Due Diligence: Review of Regulatory Portfolio

  • For the investor, or
  • To help prepare for review by investor

Other

  • Act as in-country regulatory contact for off-shore clients
  • Scientific writing, including study reports

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