BQRC: 50 Years of Combined Expertise in Biologics

Biologics Quality & Regulatory Consultants, LLC (BQRC) was founded in 2013 by Chander Gupta and Rajesh Gupta, bringing over 50 years of combined experience in the development, manufacture, and regulation of biological products, including vaccines and blood-derived products. Their expertise was developed through work with major institutions such as the National Regulatory Agency in the US (Center for Biologics Evaluation and Research, CBER, FDA), the National Control Laboratory in India (Central Drug Laboratory, Central Research Institute), and leading organizations like the National Institutes of Health (US) and the National Institute of Immunology (India). They also gained experience from prominent manufacturers and a consulting organization for biologics, including the Central Research Institute, Massachusetts Biologics Laboratory, Wyeth, Chiron, and Biologics Consulting Group.   

During his tenure at the FDA from 2006 to 2013, Rajesh Gupta observed that many innovative biologics, crucial for patient health, faced delays in availability due to incomplete or deficient information in biological license applications (BLA). These deficiencies often led to multiple information requests and complete response (CR) letters, prolonging the review process and delaying product approval. BQRC was established with the goal of expediting the availability of life-saving products by advising companies and academia on effective strategies and documentation for product development, manufacturing processes, and validations, thereby ensuring smoother and quicker regulatory reviews with minimal information requests and avoiding CR issues.