Irisol Pharma Pvt. Ltd. is a consultancy firm mainly involved in providing services to Pharmaceutical manufacturing facilities. The firm was established in Sep 2015 and is driven by a team of professionals with ‘hand on’ experience in related fields. Irisol Pharma provides services such as, 1. Quality Management Systems a. Support in initiation and implementation of Quality Systems as per the current GMP requirements. b. Gap analysis of existing systems against the current requirements and proposal of remedial actions. c. Periodic audits of the facilities and monitoring of CAPA plans and present the information on the progress to the senior management. d. Training and up gradation of employee skills in terms of current understanding to primarily create a conceptual understanding of all the activities being carried out and to direct the knowledge to improve the practices which ultimately helps build up a robust system. 2. Regulatory submission – Lifecycle management a. Review of CMC related information, preparation and submission of Drug master files/ Dossiers with authorities globally (US/EU/CEP/WHO etc.) in the formats as required by the competent authority. b. Coordination in review and updates of responses related to the queries / deficiencies from the authorities. c. Support in Lifecycle management by the way of updates and amendments. 3. Third party audits a. Carrying out Third party Quality Audit’s of current/ potential supplier’s (API’s, Intermediates and KSM manufacturers) on behalf of the client and providing audit reports followed by a CAPA action plan and follow up.