Biologics Quality & Regulatory Consultants, LLC

Vaccines

Vaccines are Unique and Complex Drugs because these are given to Healthy Population. Development and Manufacture of Vaccines of Consistent Quality require in-depth Knowledge and Understanding of Science, Regulations and Principles of Quality & Biological Standardization.

Blood-Derived Products

Blood-derived Products are Historical Biologics, going back to more than a century, Starting with Products made in Horses and shifting to Human Blood-Derived Products. Ensuring Quality of these products from the Starting Material is Critical in Safety of these Products.

Therapeutic Proteins

Genetic Engineering and Recombinant Biotechnology revolutionized generation of Therapeutic Biologics, reducing Human sufferings and Disease Burden. These products brought analytical technologies and new innovations to the manufacture of biologics.

Monoclonal Antibodies

Discovery of Monoclonal Antibodies in 1975 have brought treatment to many diseases that seemed incurable or did not have effective treatments. Monoclonal Antibodies and therapeutic proteins brought the Concept of Well-Characterized Biologicals.

Biosimilars

Biosimilars bring affordable Therapeutic Proteins and Monoclonal Antibodies to patients. Vaccines and Blood-derived Products have been historical biosimilars. Success of Biosimilars depends upon sound biological standardization and analytical comparability.

Cellular Tissue & Gene Therapy Products

Cellular, Tissue and Gene-Therapy Products are the Cutting-Edge and Most Innovative Biologics that require creative and out-of-box characterization tools based on sound science.

Total Sustainable Quality and Compliance

Strategic Planning Development & Licensing

Analytical & Serological Methods

Implementing Modern Technology in Testing

Strong Understanding of science & Compliance

Theoretical Knowledge & Practical Experience

Class-Room & Hands-on (On-Site) Training

Mission

Our mission is to use our expertise to advance the development, manufacture, and regulation of biological products, especially vaccines. We aim to accelerate the delivery of safe, innovative biological products to the public to prevent and reduce disease impact. By combining cutting-edge science with strict regulatory standards, we expedite product availability and enhance quality of life through better health outcomes.

Vision

BQRC aims to be a key player in ensuring global quality and compliance in biological product manufacturing. We help clients meet international regulatory requirements for safe, impactful biological products. Our vision includes collaborating with academic institutions, non-profits, and international organizations to support vaccine development, particularly in resource-limited settings, often providing pro bono services.

Philosophy

We navigate the complex global regulatory environment for biological products by adhering to local and international guidelines, including those from the World Health Organization. Our approach focuses on strategic planning to streamline regulatory processes, reduce redundancy, and facilitate market entry. We are committed to maintaining high quality standards throughout the product lifecycle, from development to licensing.