Biologics Quality & Regulatory
Consultants, LLC
Provides Consultation in Development, Manufacture & Regulation of Biological Products in a Dynamic 21st Century Risk-based Regulatory Environment with focus on Total & Sustainable Quality & Compliance based on Science & Law for the International Market, using Concepts of Quality by Design (QbD) & Risk Management Approaches to exceed Minimum Requirements. Combining Scientific & Regulatory Expertise with Strong Mentoring, Motivating & Decision-making Skills, and Using Modern Technologies, Strategic Planning result into achieving Vision & Mission of the Organization
BQRC Difference & Strengths
- Achieving Total Quality and Sustainable Compliance
- Strategic planning during Development of Innovative Biological products
- Understanding Science and Compliance by Staff
BQRC Services
BQRC's services are based on Science, Technical Experience, Regulations, Guidance Documents and Common Sense
Product Support
Consultation in Development, Manufacturing, Quality, Regulation of Biologics, Vaccine Adjuvants, Combination Vaccines, Polysaccharide-Protein Conjugate Vaccines
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Regulatory Support
Strategies for Licensing or Regulatory Approval Preparation of Regulatory Documents Responding to Regulatory Citations/Actions (483 Observations, Warning Letters, Information Requests,
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Strengthening Quality
Set-up of Laboratory Operations, Analytical Method Life-Cycle Management Quality Management Systems (QMS) Quality by Design (QbD), Investigations, deviations, non-conformances, out of
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Training/Coaching
Science and compliance related training, particularly on laboratory operations, analytical methods life cycle, modern methods, mentoring, motivating staff, including hands-on laboratory training
Know MoreBQRC operates on hourly and project basis.
For details of services and rates, please contact.
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, for supplyinbg 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.
Product Expertise
In addition to understanding and implementing current Good Manufacturing Practices (cGMP) regulations, knowledge about product and process is essential to achieve compliance.
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 (Equine) 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 modern facilities, 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.
Development and Manufacture of Safe and Efficacious Biologics
involve understanding Challenges and Risks, which need to be analyzed understood and ultimately resolved or mitigated. Major component in achieving compliance is "Risk Management".
Science is a beautiful gift to humanity, we should not distort it.
The scientific and technical knowledge about development and manufacture of biological products, combined with the regulatory expertise and hands-on experience are strengths of BQRC that help in devising strategies in development of a quality product with fast regulatory approval.
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
