CHIMERA GENTEC PRIVATE LIMITED” is an ISO 9001-2008 certified company. It is a leading provider of consultancy services, equipments, technologies and active raw material & finished products to Vaccine, Pharmaceutical and Bio-pharmaceutical industries all over the world. Chimera Gentec also has its state-of-the-art Technology Development Centre for Vaccines and Biologicals which is recognized by Govt. of India (Department of Scientific and Industrial Research, Ministry of Science and Technology). Chimera Gentec is executing turn-key, greenfield as well as upgradation projects all over the world including India, UK, Europe, South Korea, Bangladesh, Thailand, Egypt, Russia and China. The greenfield and turn-key projects include quality risk-based designing (including conceptualization, basic and detailed engineering) & commissioning of facilities, process development & trouble shooting, quality control, quality assurance, validation, documentation, GMP and hands-on trainings. We offer full range of regulatory support right from mock audits, regulatory submissions and support in external inspections.
We also provide full range of due diligence services for investors and collaborators. We establish manufacturing plants for our clients which have robust Quality Management System in place ensuring their compliance with regulatory agencies such as WHO, Health Canada/USFDA/EMEA FDA, EU, ANVISA, CFDA, PMDA, TGA etc. We establish Quality Management System which has advance elements such as Quality Risk Management and Continuous Improvement. We also provide hand-holding approach in ensuring WHO Prequalification of medicinal products/devices.