BQRC Story
Biologics Quality & Regulatory Consultants, LLC (BQRC) was founded in 2013 by Chander Gupta and Rajesh Gupta with more than 50 years combined experience in development, manufacture, and regulation of biological products, mainly vaccines and blood-derived products.
Biologics Quality & Regulatory Consultants, LLC (BQRC) was founded in 2013 by Chander Gupta and Rajesh Gupta with more than 50 years combined experience in development, manufacture, and regulation of biological products, mainly vaccines and blood-derived products. Knowledge and understanding in development, manufacture, and regulation of biological products was gained through working at the National Regulatory Agency (NRA) in the US (Center for Biologics Evaluation and Research, CBER, Food and Drug Administration, FDA), National Control Laboratory (NCL) in India (Biological Standardization and Quality Control Division, Central Drug Laboratory, at the Central Research Institute, Kasauli) and the US (Division of Biological Standards and Quality Control, CBER, FDA), premium research organizations (National Institutes of Health in the US and National Institute of Immunology in India), leading manufacturers of vaccines and blood-derived products (Central Research Institute in India, Massachusetts Biologics Laboratory, Wyeth, and Chiron in the US), and a consulting organization for biologics (Biologics Consulting Group).
During working at the FDA from 2006 to 2013 and gaining insights in the approval process of biological products, Rajesh observed that several life-saving innovative biologics do not become available to the needy patients at the earliest due to missing or deficient information in biological license applications (BLA), leading to several information requests (IR) and even complete response (CR) letters causing delays in reviews and ultimately delays in approval and availability of these life-saving products. There are very few products that get approved in the required timeframe (6-months for accelerated reviews and 10-months for regular reviews)due to these deficiencies and information presented in a manner that is not clear or as required or expected by the regulatory agencies.
The major goal of forming BQRC was to serve the public health by having life-saving innovative products available to the patients at the earliest by advising companies/academia on strategies and documentation on development of product, manufacturing process, and validations, that are expected or required by the regulatory agencies, so that the regulatory reviews on BLAs are fast and smooth with minimal information requests and no CR issues.