Expert Quality Assurance Audits for Pharma and MedTech

Quality assurance (QA) and compliance are important considerations for any company. Prioritizing QA ensures that there are no gaps in compliance and keeps your market success rates healthy.

FDA Quality and Regulatory Consultants (FDAQRC) is an international quality audit provider for the pharma, biotech and MedTech industries, offering top of the line contract audit services. We are committed to making quality assurance and compliance achievable.

Analyze Your Processes with an FDAQRC Quality Assurance Audit

Our quality assurance audits can help elevate your standard operating procedures (SOPs). We pride ourselves on maintaining excellent Good Practice (GxP) compliance. This means you experience fewer gaps in your quality assurance and more confidence in your risk identification. Our teams are trained to provide services that leave our clients feeling secure in their systems and processes.

As part of a quality assurance audit with FDAQRC, we offer the following services:

  • Pharmaceutical and biotech audits: We provide comprehensive GxP audits, including GCP, GMP ,GLP, GCLP, and GVP, that help you stay compliant at every stage.
  • Supplier and vendor audits: Our supplier quality audit program enhances your supply chain and reduces the risk of working with third-party vendors.
  • International  audit solutions: Comprehensive on-site audit support delivered across dozens of countries worldwide.
  • Remote audit solutions: Efficient remote audit services providing global coverage without geographic limitations.
  • Medical device inspection: We perform mock inspections and thorough audits to ensure you are prepared for regulatory scrutiny.
  • CRO and CMO audits: We provide detailed audits for contract research organizations (CROs) and contract management organizations (CMOs).

Maximize Compliance with Regular Quality Assurance Audits

Quality assurance audits are a necessity in the pharma, biotech and MedTech industries. Ensuring compliance indicates professionalism and commitment to key standards. Our specialists at FDAQRC have conducted extensive QA audits across global markets and enabled countless businesses to deliver the highest quality services at every stage. There are many benefits to conducting regular quality assurance audits:

  • Ensure regulatory compliance: Regular QA audits help your company adhere to industry standards.
  • Enhance operational efficiency: A QA audit will reveal inefficient workflows and inadequate practices.
  • Reduce risk and costs: You may see significant risk reduction with regular QA audits.
  • Improve product and service quality: Audits identify inconsistencies in procedures to help you stay compliant.
  • Support continuous growth: High compliance presents the opportunity for continuous growth.

Why Choose FDAQRC for Your Quality Assurance?

Since 2009, FDAQRC has remained committed to providing high-quality pharmaceutical audits for the pharma, biotech and MedTech industries. We have a global network of more than 500 vetted consultants who are experts in the field, with many being former regulatory professionals and FDA personnel. We maintain the highest level of team excellence possible to ensure that you experience expert quality assurance.

Take the Next Step Toward Quality Excellence with FDAQRC

FDAQRC’s expert auditors help you identify risks and strengthen compliance for a robust and resilient quality assurance system. Contact FDAQRC for a personalized consultation today to stay compliant and manage risk reduction with the help of our experts.

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