BQRC Difference & Strengths

Achieving Total Quality and Sustainable Compliancefor Biologics in a dynamic Regulatory Environment (current Good Manufacturing Practices, cGMP) not only requires expertise in regulations and law governing these products, a thorough knowledge, understanding and practical experience in development and manufacture of these products are essential. The scientific and technical knowledge about these products combined with the regulatory expertise and practical experience ensure total quality and compliance, exceeding minimum requirements of international regulatory authorities. BQRC offers such expertise (Compliance Through Science with a concept of Good Scientific Practices with Common Sense).

Strategic Planning during Development of Innovative Biological products based on Strong Science and knowledge about process and product, including Critical Quality Attributes, Critical Process Parameters and Critical Starting Materials and knowledge and understanding about regulations and Regulatory Guidance, including appropriate and Scientifically Sound Analytical Methods “Suitable for Intended Purpose”, Characterization and testing at various Stages of Manufacture, Quality by Design (QbD) concept, Validations, Specifications, etc. will bring the products faster to the market by smooth regulatory approvals. BQRC provides such service.

Modern Technology based on Proteomics, Genomics, Massive Parallel Sequencing, Modern Microbiological Methods, etc. has not been used often in Testing and Characterization of Biological Products, particularly legacy products. These methods will not only provide better analytical methods in terms of accuracy and precision, but will help in speed in testing product, ultimately reducing the time taken to manufacture product and help in better understanding of the product, leading to improving the products in terms of safety and efficacy. BQRC has such expertise.

Understanding Science and Compliance by Staff is critical in achieving Total Sustainable Quality. People do a great job when they understand the job and its impact on the quality of the product. It takes time to mentor, coach and motivate people. BQRC has unique scientific, regulatory, inter-personal and results driven skills to Train Staff in a scientific environment with respect for scientific dissent and independent thinking, but with a focus on results emphasizing the need of decision making to achieve the vision and mission of the organization.