Life cycle maintenance, Gap Analysis & Variation applications

During the life cycle of the medicinal product a number of changes may occur which affect its quality, safety and efficacy with direct impact on the requirements and terms laid down by the marketing authorisation (MA) under which the marketing of a medicinal product is authorised in the EU.

The variation regulation (EC No 1234/2008) which governs the procedures for the amendment of the decision granting the marketing authorisation and of the technical dossier needs to be satisfied; should the marketing authorisation of the medicinal product is maintained. Following are the services provided:

  • Carrying out Gap Analysis and reviewing the current regulatory status of the medicinal product.
  • To draw a regulatory strategy required for reconciling the current practice and documentations with the terms of the MA license granted.
  • Assist in reviewing the documentation to ensure proper QA control reflecting the current status of the medicinal product license. This is in preparation for inspection by MHRA or other competent authority from EU.
  • Preparation of the variation application and the relevant modules of the dossier including SmPC, PIL and labelling ensuring compliance with current requirements.
  • Writing QOS module (M2) to discuss the changes proposed and level of compliance with the current regulatory and scientific requirements.
  • Maintaining the current license of the finished product and renewal.