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Ensuring Quality, Integrity and Compliance.

Achieve Your Goals

QC SERVICES

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Expert Guidance

QA SERVICES

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Grow Your Business

PROJECT MANAGEMENT

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Welcome To BioPharma Consulting Group

Experienced consultants that share your commitment to the highest standards for efficacy and patient safety

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.

BCG provides 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.

About Us

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.

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 manage major and critical projects with minimal training and direct onboarding.

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.

Qualified Professionals

Reduction in Hiring Costs

Committed to Excellence

Why Choose BCG?

Qualified Professionals

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.

Reduction in Hiring Costs

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 manage major and critical projects with minimal training and direct onboarding.

Committed to Excellence

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.

Biotech & Pharmaceutical Consulting Services

Quality Control

Our Quality Control Consultants will follow and establish well-defined controls through procedures bringing value to our clients by meeting the product quality needs and expectations at every step from development to commercial final product release.
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Quality Assurance

Our Quality Assurance services focus on improving quality, integrity and compliance by providing certainty of the product and data. Guaranteeing effectiveness and efficiency as per client expectations and regulatory requirements with regard to patient safety.

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Project Management

BCG will manage client projects with technical competencies focused on quality design efficiency through customized strategies to meet all company goals and produce completed projects compliant to objectives and timelines.

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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

Chris is a great Quality Lead for any start-up life sciences company.

Chris has worked for several bio/pharma start-up companies. In some cases, the Quality laboratories did not have any equipment, or the business site had not experienced their first audit. He was responsible for building Quality Control/Assurance departments, determining organizational structure, hiring teams and product manufacturing planning. This resulted in successful regulatory audits to obtain GMP manufacturing certificates, site commercial manufacturing, and approval to distribute medicinal products to targeted markets.

Start-up companies always face the challenge of working with limited resources. In start-ups, Chris assisted with hiring general contractors to perform all new equipment purchasing, intake, IQ/OQ/PQ, and he managed equipment calibration timelines, with QC/QA oversight and approval of all contractor activities. In addition, he contributed to hiring FTE laboratory personnel to establish essential laboratory workflows and processes such as 6S, Kanban, housekeeping, glass washing, gowning, storage unit alarm response, sample management and quality systems (deviations, investigations etc.). He also created lab work instructions (SOP’s and Protocols), enabling the companies to perform transfer work once new equipment were GMP released for use and prepared for commercial manufacturing.

Start-Ups with Limited Resources