Product Life Cycle Management

  • Product variation / amendment application - Defining the type of variation (Type I or Type II for EU, PAS, CBE 30 or APR for USA), reviewing technical data, preparation of application and submission to health authority
  • Product Renewal or Re-registration - Suggesting/filing for renewal / re-registration application, well in advance to avoid de-registration of the product
  • Renewal of manufacturing Site GMP - Timely preparation and submission of renewal application for Site GMP
  • Renewal of BE center GCP certification - Timely preparation and submission of renewal application for BE Center
  • Annual Product Review submission - Preparation and submission of Annual Product Review to health authority