Establishment License approved by HC in order to import and offer APIs in Canada

Client Type: Active Pharmaceutical Ingredient(s), GxP System, Regulatory Inspection

Jurisdiction(s): Canada

Services Provided: Created SOPs as per API guidance. Reviewed a temperature monitor study and GMP evidence of suppliers to ensure application acceptance. Filed an Establishment License with Health Canada, Self Inspection report on Logistic provider and technical agreement with Logistics provider.