Market Approval: An application for market approval must document safety and efficacy information of the investigational drug and contain all the information collected during the drug development process. At the conclusion of successful preclinical and clinical testing, this series of documents is submitted to the Food and Drug Administration (FDA) in the U.S. or to the applicable regulatory authorities in other countries. The application must present substantial evidence that the drug will have the effect it is represented to have when people use it or under the conditions for which it is prescribed, recommended or suggested in the labeling. Obtaining approval to market a new drug frequently takes between 6 months and 2 years.

Market Approval Services that can be outsourced on CanBiotech include:

Regulatory
  Compliance
  Licensing
  Monitoring Clinical Trials
  Registration
  Regulatory Submissions

Compliance
  FDA-U.S.
  GCP
  GLP
  GMP
  HPB-Canada