GxP Compliance Services

Product quality is essential for the efficacy and safety of pharmaceuticals, biotechnology, and medical devices. FDA Quality and Regulatory Consultants (FDAQRC) provides GxP compliance consulting and implements various practices to ensure your product maintains high standards throughout its life cycle.

Our GxP Compliance Solutions for Life Sciences

We can follow your product throughout its life cycle and development, from quality audits to mock inspections, gap assessments, and more. We can pair our clients with experts for every project, regardless of location, utilizing our global consultant network. FDAQRC can assist you through any stage of your journey in any of the following categories and beyond.

Clinical and Laboratory Compliance

At FDAQRC, our compliance experts can accurately follow clinical trials and laboratory testing for quality management. Key regulations include:

• Good Clinical Practice (GCP): GCP standards recognize ethical and scientific quality in designing, recording, conducting, and reporting clinical trials with human subjects.
• Good Laboratory Practice (GLP): GLP refers to quality management controls that ensure the reliability, integrity, and consistency of non-clinical laboratory studies.
• Good Clinical Laboratory Practice (GCLP): We use GCLP standards to ensure the reliability, quality, and integrity of the laboratory data generated during your clinical trials.

Manufacturing and Production Compliance

We can start with manufacturing and production at the beginning of the life cycle. FDAQRC follows these regulatory standards to ensure compliance from design to production:

• Good Manufacturing Practice (GMP): GMP is a set of principles and procedures that confirm pharmaceutical, biotech, and medical device products consistently meet quality standards. We follow GMP standards to minimize the risks involved in manufacturing processes and ensure products are free from contamination, mix-ups, defects, and other errors.
• Good Distribution Practice (GDP): GDP includes various quality standards that ensure pharmaceutical products are correctly stored, transported, and appropriately handled throughout the supply chain. This practice can give your company peace of mind, knowing we look out for product quality and integrity.

Technology and Safety Monitoring Solutions

Automation and advanced technology can make our processes more efficient, but FDAQRC adds an extra layer of protection to make sure no regulations are sacrificed along the way. Some technology and safety monitoring solutions we provide include:

• Computer system validation (CSV): CSV is a process that maintains computer systems used in regulated activities, securing them for reliability, data integrity, and patient safety.
• Pharmacovigilance services (GVP): Pharmacovigilance uses cutting-edge science to detect, assess, understand, and prevent adverse effects in pharmaceuticals, biotechnology, and medical devices.

Request a GxP Compliance Consultation Today

If you’re ready to get started, contact us today. We will schedule a one-on-one consultation with a GxP consultant to discuss the details of your upcoming project.

Request a Consultation