Dr. Rajesh K. Gupta is a Principal Consultant at Biologics Quality & Regulatory Consultants, LLC (BQRC) with extensive expertise in the development, manufacture, and regulation of biological products. With a strong focus on achieving total and sustainable compliance, Dr. Gupta employs modern concepts such as Quality by Design (QbD) and Process Analytical Technologies (PAT) to navigate the complex 21st-century regulatory environment. His in-depth knowledge helps clients stay ahead of evolving regulations by integrating scientific and legal perspectives into strategic planning.

Scientific/Technical Expertise

• Scientific expertise and understanding of life cycle of biological products from discovery to commercial manufacturing.
• Life cycle management of all types of analytical methods for products testing and characterization, including bioassays, and pre-clinical and clinical serological methods, including functional assays, from method development to validation under appropriate regulations (GXP).
• Implementation of genomics, proteomics, analytical & microbiology based modern methods for testing & characterization of biologics.
• Science and compliance based development and testing strategies with appropriate data driven specifications for starting materials and reagents (cell banks, seeds, reference standards, critical reagents, controls), intermediates (viral harvests, purified bulks), drug substance (formulated bulk) and drug product.
• Strategic planning in use of adjuvants & delivery systems to maintain a balance between toxicity & adjuvanticity depending upon risk/benefit of product.
• Equipment qualification, process optimization and validations, defining critical quality attributes, critical process parameters, critical starting materials, etc.
• Selection of appropriate technologies and process for manufacture of products in an efficient and compliant manner.
• Formulation strategies for biological products, particularly combination vaccines (e.g. to avoid carrier specific epitope suppression, antigenic competition, interference between components).
• Experimental design, data interpretation, trending, tracking, appropriate statistics, etc.

Total and Sustainable Compliance

• Develop master plans with timelines and responsibilities and quality systems for life cycle of the product under appropriate regulations, e.G. Pre-clinical studies under GLP, clinical trials under GCP and clinical development and commercial manufacture under cGMP.
• Sound knowledge of international regulations, and smart and strategic planning leading to design and set-up of facilities, utilities, processes and quality systems in a manner to meet or exceed all international regulatory requirements.
• Develop sound, but flexible policies and guidelines & SOPs to meet or exceed cGMP, safety & environmental regulations for complex biological products.
• Develop appropriate risk management strategies and tools for Investigations, deviations, non-conformances and changes with in-depth scientific root cause analysis to improve quality of the product.     

Interpersonal Skills

• Excellent mentor, coach and motivator with clear vision, strategic plans, sound & timely decision-making skills, respect for people.
• Motivate people in implementing cGMP regulations, new technology & corporate policies by explaining rationale for science and compliance.
• High degree of professionalism, think out of box, creative, sense of urgency.
• Dynamic leader, focused, well-organized, result-oriented with a track record of achievements and meeting commitments.
• Excellent networking and credibility among regulatory agencies, industry & academia.
• Excellent successful collaborations with strong skills in getting funding for projects.

Regulatory Aspects

• Expertise in dynamic & modern 21st century-based regulations, including quality by design (QbD) concept, risk based cGMPs, process analytical technologies.
• Expertise in audits & inspections – corporate, regulatory agencies, PAI, team biologics.
• Responding to regulatory citations (483 observations, warning letters, etc.) and information requests, complete response letters received in response to license applications.
• Strategic planning in generating IND applications, biologics license application (BLA) or new drug application, (NDA), supplements to BLA.

Call him at 845-300-7067