Services*
- Development, manufacturing, quality and regulatory aspects of biological products
- Internal audits for due-diligence and for preparation of regulatory inspections
- Assist in responding to regulatory citations (483 observations, warning letters, etc. and information requests and complete response letters received during licensure)
- Consultancy in Investigations, deviations, non-conformances, out of specifications (OOS) results with science and logical based root-cause analysis, leading to long-term and sustainable corrective and preventive actions (CAPA)
- Scientific and compliance advice on vaccine adjuvants, delivery systems, combination vaccines focusing on a balance between toxicity and adjuvanticity of adjuvants and risk/benefit of the product
- Science and compliance related training, particularly on laboratory operations, analytical methods life cycle management, modern methods, mentoring, motivating staff, including hands-on laboratory training (on-site), where possible.
BQRC operates on hourly and project basis.
For details of services and rates, please contact.
How do we work?
Philosophy in Providing Consultancy
BQRC understands the nature of global business for biological products and complexity and heterogeneity of regulatory requirements of different countries and regions. For a successful and productive, global supplier of quality products, the companies don’t have to only implement regulatory requirements of the countries they want to market the products, they also have to meet the guidelines of international bodies, such as World Health Organization, supplying products to UN bodies. Companies have to implement new set of regulatory requirements to enter a new market. BQRC will strategize to develop requirements with a view to meeting or exceeding the key markets, companies want to market the product to avoid duplicate operation, testing and lot release requirements.
Achieving total and sustainable quality and compliance in a dynamic and ever-changing regulatory environment for biological products needs strategic thinking and planning in developing corporate polices, standard operating procedures and other operating documents. BQRC provides significant focus on this aspect.
Licensing innovative products in a timely manner needs strategic planning during product development, developing testing and characterization methods and establishing specifications. BQRC has expertise and understanding of these aspects and will provide advice during development of the product and writing a licensing application.