Welcome to IRISOL Pharma Pvt. Ltd.

“Hands-on” experience with practical understanding and interpretation in the implementation of Quality Management Systems for pharmaceuticals is the current requirement of the industry. Irisol Pharma, the Consultancy Services Firm, caters to the current aspirations of the Industry to excel in terms of Regulatory Compliance. The contemporary thought processes related to the Pharmaceutical Quality Management Systems are given the impetus by the Team Irisol Pharma in its objective to provide the necessary support in continually re-defining and revamping the systems at its Client’s Facilities. With the changing Quality dynamics from Testing and Inspection Approach to PQMS and the focus shifting to the critical aspects of Data Integrity, Quality Risk Management and Root Cause Analysis, it is imperative for the Industry to develop systems and procedures that help build up a holistic approach towards Compliance. Thus IRISOL aims at being part of the QMS improvement process taken up at various Organisations and help evolve a robust system that suits the current Regulatory scenario which calls for compliance to regulations getting stringent by the day.

The Team - Combined experience of 50 years and more in QMS and RA.
The Team at Irisol, with its experience in implementation of Quality systems that are in tune with the current global scenario and monitoring of the same, can undertake the activity of performing gap analysis at the Organisation vis-à-vis the requirements and help devise action plans for improvements and ensure Inspection-readiness. With its expertise, Irisol intends to help Organisations to build up effective post-inspection CAPA plans with sound scientific and technical rationale, that help them in maintaining their business relations with the Customers and also ensure an approved state with respect to the requirements of the Health Authorities. The experts have handled about 60 regulatory authority inspections from different regulatory authorities across the world, including the US FDA, MHRA, TGA, PMDA, COFEPRIS and ANVISA.
IRISOL team has also the experience and background in Regulatory Submissions with the Authorities globally, particularly in terms of the Drug Master Files. Rich hands-on experience in having submissions with USFDA, Health Canada, TGA, PMDA, EU, WHO-GENEVA and other Agencies in support of various applications, preparation and submission of responses to the Queries/deficiencies raised during the course of review of the Marketing Applications forms the back-bone of the Regulatory Support.
The Activities of Irisol are managed by the Team of three who are supported by an additional group of experts who have gained rich experience by way of working in Organisations of repute and commitment to Compliance