Achieve Your Goals

Expert Guidance

OUR MISSION

Ensuring Quality, Integrity and Compliance in the Workplace.

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 quality control and quality assurance 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. 

 
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OUR SERVICES

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 & Compliance

Analytical Method Development To Validation​

Analytical Equipment Qualification to Validation

Quality Systems
(Investigations, Deviations, Etc.)

Establishing Stability Programs

Audit Preparation

Quality Training

 

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.

 
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WHAT OUR CLIENTS SAY

Chris’s work ethic and style assure the achievement of a company’s diverse objectives.

 

In South East Asia, Chris worked for 2 global pharmaceutical companies, both seeking managers interested in working overseas.  Each company wanted a proactive approach to promoting diversity and inclusion in business operations and workflows.  He added value by providing international experience and innovative thinking practices. In working successfully with people from around the world, he gave each company a cutting-edge advantage in work policies and platforms.

 

Chris provided his Quality expertise and developed partnering relationships by adapting to the different work and social cultures of each company.  He leveraged his experience with various pharma companies and regulatory agencies to the successful application of best practice approaches throughout all Quality Control/Assurance processes.

International Experience

 

CONTACT US

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