We Coordinate with Drugs Control Department and DCGI, State drug controller for Manufacturing License, GMP certificates, free sale certificates, Certificate of Pharmaceutical Product (COPP), wholesale license, DCGI, NOC DCGI, LLIN Registration with Central insecticide board/National Institute of Malaria Research, NOC from Central Bureau of Narcotics, etc.
Experience in handling deficiencies arising from MOH and regulatory authorities and resolving the queries as requested by the Customers and Regulatory Agencies
In-depth understanding and knowledge of GMPs, US FDA, MHRA UK, EU, ANVISA Brazil, TGA Australia, MCC South Africa, ICH Regulatory guidelines, ANDA/DMF filing for advanced markets.
We offer comprehensive knowledge in Regulatory Affairs/CMC writing/ANDA/ANDs submissions in Pharmaceutical companies for US/Canada/EU/ASEAN countries/AFRICAN countries and Row markets from development to market and beyond, from clinical to post-approval and compliance work.
