Regulatory Affairs

PharmaCqARE acts on the behalf of any Health Authorities or any other third party in the following activities :

  • Review, assessment of any Marketing Authorisation Application dossier concerning products already authorized in any other territories or product never approved in any territories
  • Provision of Assessment Reports with list of questions and communication with the Marketing Applicant
  • Assessment of Authorisation Renewal and Benefit/Risk balance
  • Review and assessment of clinical trials applications
  • Discussion of Regulatory and legal environment

PharmaCqARE :

  • Helps in developing local customized regulatory strategies
  • Writes any regulatory documents or reports
  • Performs a regulatory survey on ICH environment (Europe (EMA), US (FDA), Japan (PMDA)