Good Clinical Practice 

Your clinical trial’s success — and your company’s reputation — hinge on meticulous adherence to Good Clinical Practice (GCP). As a global leader, FDA Quality and Regulatory Consultants (FDAQRC) partners with organizations to navigate complex GCP requirements, including alignment with ICH E6 (R3) standards.

Navigate Good Clinical Practice Compliance With Confidence

When clinical trials involve human subjects, GCP guidelines establish the ethical and scientific benchmarks for everything from trial design and conduct to data recording and reporting. Noncompliance is a high-stakes issue, carrying the risk of costly product recalls and regulatory sanctions.

FDAQRC’s GCP compliance services can protect your company’s reputation and financial stability by ensuring compliance with evolving standards from:

  • The U.S. Food and Drug Administration (FDA).
  • The National Institutes of Health (NIH).
  • The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
  • Other global health authorities, including the European Medicines Agency (EMA), Health Canada, the Medicines and Healthcare products Regulatory Agency (MHRA), and the Pharmaceuticals and Medical Devices Agency (PMDA).

We deliver customized solutions and standards that streamline compliance, safeguard patient safety and shield data integrity. With us, you can minimize regulatory risk while optimizing business efficiencies.

Our Good Clinical Practice Compliance Services

FDAQRC delivers a hands-on, expert-led approach to simplify compliance management. We can follow your product across its life cycle and development, from risk-based quality audits and gap assessments to mock inspections. We’ll match you with the right specialist for every project to deliver customized GCP training, regardless of your location.

GCP Audit Solutions

FDAQRC’s global consultant network has supported clients end-to-end, including preparation and hosting as well as post-audit remediation. Our team includes former experts from the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other health authorities, who understand what auditors expect and how to prepare teams effectively.

We deliver:

  • Personalized audit readiness programs. 
  • Risk-based mock audits help to identify and address gaps early. 
  • Subject Matter Expert coaching. 
  • Corrective and Preventive Action development and implementation. 
  • Investigator Site Audits, Trial Master File (TMF) Audits, and Vendor Audits to ensure comprehensive oversight and data integrity

When your company is preparing to host critical clinical or vendor audits, FDAQRC helps ensure your team is compliant and prepared.

GCP Inspection Readiness Programs 

With proactive planning and oversight, FDAQRC helps you maintain an inspection-ready organization at all times. Our experts and former regulators deliver full-spectrum inspection readiness programs and on-site support to streamline every step and reduce pressure. If your company is anticipating a routine FDA inspection, partnering with us gives you the peace of mind that your team will be professional and prepared, minimizing stress and driving a predictable process.

Quality Management System Support

Maintaining an effective Quality Management System (QMS) can be a complex, resource-intensive process. FDAQRC works with your team to design, implement and optimize a QMS that integrates quality in every workflow, simplifies workflows and enhances data integrity.

We offer support by:

  • Aligning processes with the FDA and ICH’s GCP expectations. 
  • Standardizing and rationalizing Standard Operating Procedures to reduce complexity.
  • Defining metrics that reflect QMS practices
  • Enabling continuous improvement to minimize defects, deviations and rework costs. 

FDAQRC provides specialized GCP services, including:

  • Gap Assessments and Mock Inspections
  • Investigator Site, Vendor, and Trial Master File Audits
  • GCP Training and Remediation Programs
  • Risk-Based Quality Management and CAPA Implementation
  • Inspection Readiness and Post-Audit Support
  • Support for ICH E6 (R3) compliance in Clinical Study Report preparation and review

Why Partner With FDAQRC?

Since 2009, FDAQRC has delivered compliance services to biotech, pharmaceutical and medical device companies around the globe. Here’s why partnering with us makes sense:

  • Expert GCP consultants: Our approach to GCP compliance begins with our scientific and technical specialists, who bring deep expertise in quality and compliance. We’ve continued to grow, expanding our worldwide capability and knowledge. 
  • Client-centric compliance solutions: Each product and program is as unique as our clients. We tailor assessments, strategies and implementation plans to your industry-specific product requirements and standards.
  • Full life cycle support: From early research to post‑market, we drive implementation and continuous improvement. Our vetted global network of over 500 consultants, operating in more than 70 countries, supports your product’s alignment with international requirements.

Partnering with FDAQRC enables you to stay focused on core priorities with confidence that your clinical trials are ethical, compliant and ready for inspections and audits. Contact us today to schedule a consultation and review your specific GCP requirements or learn more about our services. 

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