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Validation Engineering

The Key to an effective Quality Management System (QMS) is to have your QMS aligned with your business needs. BCVS helps Pharmaceutical, Biotechnology; Medical Device companies achieve compliance with FDA, EMEA, ISO, and other recognized standards.

Our clients understand the importance of establishing a robust quality system designed to meet ISO quality management standards. The effort in maintaining a strong quality system not only ensures that the products and services meet the customer expectations and fulfil the regulatory requirements; it directly benefits our clients’ business through effective production process and successful regulatory audits.

BCVS can assist your company in the planning, design and implementation of a quality system designed to meet the standards of your choice including ISO 9001, ISO 14001, ISO 13485, ISO 17025, ISO 16949 or OHSAS 18001. We can help develop a system that is understandable and practical to maintain.

We have many years of experience serving renowned clients in biotechnology, pharmaceuticals, medical devices and industries. We follow a systematic approach to identify, assess and successfully resolve various quality issues.

We are proud to offer you our world-class quality system services in the following:

  • Quality management consultation and training
  • ISO and cGMP implementation
  • Gap and quality performance analysis
  • Quality System Documentation
  • Audit and inspection Readiness and Remediation
  • CAPA
  • Compliant Handling

How can we help?

Have a Quality System that is not working for you? Received a 483 or a warning letter? Your Quality System can be evaluated and revised/rebuilt to meet the requirements.

BCVS examines an organisation's QMS in conjunction with its business model. We then strategise using smart tools and data to development and implement your new and improved Quality System. Get in touch to learn more about how this service can help you.