Ensuring Quality, Integrity and Compliance in the Workplace.
BIOPHARMA CONSULTING GROUP WELCOMES YOU
Our mission is to assure pharmaceutical efficacy and patient safety at the highest standards through a well-defined focus on Data Integrity, Quality and Compliance.
We provide unique expertise in managing particular laboratory functions; balancing workload delegation and distribution; addressing issues that arise in critical and unexpected projects. Our extensive technical competencies are in a variety of Analytical and Bioassay methods, performing assays, reviewing data and in leading projects such as method validations and transfers. Our qualified professionals will have a direct, positive impact as project managers on a variety of critical tasks, significantly reducing the need to hire additional Full Time Employees (FTE’s), who must undergo extensive training before assuming responsibilities.
We are a perfect fit to prepare your teams for upcoming audits, both internal and external (regulatory and customers) because of our rigorous audit preparation platform and our experience with a number of regulatory agencies including: United States FDA, Europe EMA, Japan, Brazil and Turkey.
HOW WE DO IT...
1. Understand and Evaluate project needs.
2. Through Cognizant Examination and Planning, Integrate a successful strategy.
3. Collaborate and Align on the proposed plan.
4. Implement, Perform and Succeed.
WHAT WE DO...
BCG provides patient passionate consultation services to small, medium and large sized Biotech and Pharma companies. Our services include Quality Control, Quality Assurance and Project Management laboratory support (Raw Materials, Biochemistry, Analytical/Physical Chemistry and Microbiology) in the following areas:
Sample Management (sample receipt, storage, result release and disposition)
Data Integrity and Compliance
Analytical method development to validation
Analytical equipment qualification to validation
Quality Systems (investigations, deviations etc.)
Establishing stability programs
WHY CHOOSE BCG...
We are qualified professionals with expertise specific to Quality design. BCG consultants focus and specialize in providing Quality Control (QC) and Quality Assurance (QA) capabilities in Analytical theory, testing, equipment and applications. Our niche in pharma quality analytics allows us to deliver the best results to our clients.
We manage major and critical projects with minimal training and direct onboarding, reducing the need to hire additional FTE’s with long training periods.
Based on our inspection and audit experiences BCG can make your next regulatory audit stress free, assisting our clients with remediating any cGMP concerns, prior to the inspection date, with a guarantee that laboratory processes follow all quality, data integrity and compliance expectations above and beyond industry standards.