Carexa Inc.

2112 Pinevalley Cres.,
Oakville, ON L6H 2L8 Canada
(905) 338-0909
fax: (905) 338-1010

 

About Us

Services

 

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Our Services

Strategy & Planning

  • Development of regulatory strategies
  • Assessment of existing regulatory strategies and timelines
  • 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 (NDA/BLA, NDS, MAA)
  • Updating 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 a review of your portfolio by investor(s)

Other

  • In-country regulatory contact for off-shore clients
  • Scientific writing, including study reports

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