Quality Assurance Services for Pharma, Biotech and MedTech
In the high-stakes pharma and MedTech industries, the line between market success and costly delays is drawn by quality assurance and compliance. FDA Quality and Regulatory Consultants (FDAQRC) is committed to helping companies and organizations in these industries maintain compliance and deliver high-quality solutions to the end user. We make this possible by providing life sciences quality assurance (QA) services that help you manufacture safe and effective products while minimizing noncompliance risks.
Our End-to-End QA Services to Achieve GxP Compliance
Maintaining Good Practice (GxP) compliance is a complex operational responsibility. Understanding these requirements is only half the challenge — the other half is integrating them into each department, from the lab to the manufacturing floor.
FDAQRC specializes in solving this integration challenge. We offer QA services that cover the entire life cycle of your products, helping you remain compliant with all GxP standards and ensure consistency at every stage of manufacturing.
These GxP standards are the foundation for all our QA services:
Quality Assurance Audits
Our QA audits evaluate your SOPs and are essential to identify gaps in your compliance. These thorough audits serve as a proactive measure to prepare your company for successful regulatory inspections and reduce the risk of penalties due to noncompliance.
At FDAQRC, we have conducted over 5,500 global audits in 75 countries since our establishment in 2009. As part of our SOP compliance consulting, we offer auditing capabilities that include:
- Vendor qualification audits
- CRO/CMO audits
- GxP gap analysis
- For cause audits
- Mock health authority inspection audits
- CSV compliance audits
- Investigator site audits
Quality Management System Services
We design and build MedTech, biotech and pharmaceutical Quality Management Systems (QMS), helping you set up and enhance policies and procedures to ensure quality at every step. Our GxP QMS improvement solutions are efficient, scalable and practical for your company’s unique daily operations.
Our QMS solutions can be both proactive and reactive. We have the expertise to provide strategic improvement for existing and new systems while also delivering problem-solving solutions for companies facing compliance issues.
Whether you require proactive or reactive services, our biotech, medical device and pharmaceutical QMS consultants handle everything from implementation to optimization, integrating essential digital tools and training staff to use the QMS efficiently.
Qualified Persons Services
FDAQRC provides Qualified Persons (QP) services to companies in the UK and EU to improve compliance and product release efficiency. We have over 20 full-time biotech, MedTech and pharmaceutical quality consultants located across Ireland, the United Kingdom, France, Italy, the Netherlands, Germany and Macedonia.
Our QP services are critical to support your market access goals in Europe and ensure your products meet the necessary standards before release.
What Qualifies FDAQRC as Quality Assurance Experts?
In addition to our full-time consultants, we have a network of over 500 consultants worldwide with various backgrounds. This elite team includes industry experts with an average of over 15 years of experience each, former FDA personnel and credentialed healthcare professionals.
Our commitment to excellence and our vastly experienced team enable us to deliver the highest standard of global compliance services.
Partner With the Experts in Quality Assurance
To maximize biotech, pharmaceutical and medical device compliance at each stage of manufacturing, trust FDAQRC for unmatched QA services. Get in touch with us today to schedule a one-on-one consultation.
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