Regulatory Affairs

The Regulatory Affairs department ensure that all pharmaceutical products comply with regulations governing the pharmaceutical industry (GMP requirements), handle presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the product concerned. Besides, this department works at each level from the initial application phase of the new drug to the licensing and marketing stages, making sure that all operations and products meet required safety, stability, and efficacy standards. Canadex offers outsource and out task regulatory affairs consultancy, including formulation development, clinical trials, stability studies.