Your Partner in Evaluating, Mitigating and Reversing Compliance Risk


We help Life Science Industry comply with various regulatory standards.
ISO 9001; ISO 13485 and prepare associated scientific documents

Inspection Readiness

Reduces Costs and Avoids Delays Right Before Market Launch with Continuous Preparation for Inspection Readiness.

Audit and Gap Analysis

Prevent Delays with Periodic Check of Internal Processes and Supplier Base.

Regulatory Strategy

Allocate Resources Judiciously with a Strategic Plan for Regulatory Filing.

Scientific and Technical Writing

Reduce Deficiency Letters from Agency Through Clearly Written, Well Summarized Technical Information.

About GBR Inc

GBR is a Woman Owned Small Business founded in 2006 and based in California.
We mitigate risk with a multi-lingual, globally accessible team.

Global Biopharmaceutical Regulations Inc., (GBR) helps an enterprise evaluate, manage and reduce regulatory compliance risk. We partner with our Client to analyze data, reverse risk, implement process efficiencies and develop documentation to reflect a continuously improving organization. We help with audit of suppliers, laboratories, and manufacturing facilities. All our associates and partners have advanced degrees of relevant disciplines and also carry licenses for their area of expertise whether it is Quality Management Systems, Environment, Food Safety or Occupational Health and Safety.

  • ISO 9001; ISO 13485; ISO14644

    Auditing/Gap Analysis for GMP Compliance

  • Pre-approval inspection preparation

    Prepare/Stage Document, Rehersal with Subject Matter Experts

  • Scientific Writing

    Changes to Manufacturing Process During Clinical Trials and Post Market Launch

  • Briefing Documents

    Preparation towards Regulatory Agency inputs

What Our Clients Think of Us

Past Performances

Recent News

A Collection of Recent Articles, Events and Speaking Engagements

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