Good Clinical Practice (GCP) Quality Assurance (QA) support includes any activity that sustains a company’s compliance with GCP guidelines (i.e., analyzing metrics, assessing ineffective workflows, preparing cross-functional teams for regulatory authority inspections, evaluating the impact of new regulatory guidance, writing and reviewing Quality Management System [QMS] documents, etc.). Your company’s compliance with GCP guidelines cannot be achieved without constant vigilance.
Our Approach
By partnering with RegDev, your company adds decades of accumulated knowledge, experience, and a vast network of professionals to the process of holistically assessing existing clinical, nonclinical, operational, and regulatory procedures. Identified gaps are discussed and, with an agreed plan to close those gaps, RegDev works behind the scenes to offer periodic updates so that you can focus on larger concerns.
Organizations must prioritize GCP into every step of the drug development lifecycle so that they are not left scrambling to close gaps shortly before an Inspector arrives on-site. Allowing experienced RegDev professionals to manage the majority of this task not only reduces the burden from the client’s team members, but it also demonstrates a commitment to complying with GCP expectations .
Inspection Readiness
Ongoing Compliance
Gap Assessment
Quality Management Systems
LMS Maintenance
Partnership Focus
Focus on the Highest Priorities
While QA support of GCP activities is critical to drug development, key tasks can easily be overlooked. RegDev’s GCP QA support allows clients to focus on high-priority goals while our team handles daily tasks like analyzing and reporting on training compliance metrics, maintaining Learning Management System (LMS) activities, and updating QMS documents based on a periodic review period.
Reduced Team Burden
RegDev consultants have a depth of experience and industry knowledge that allows them to deftly manage the majority of the tasks required for GCP QA Support. Cross-functional teams can often become overwhelmed by this task and may become overworked and distracted from other important inspection preparation activities. Our team will partner with you to alleviate this stress and ensure you’re ready for inspection.
Partnership Emphasis
RegDev’s emphasis is on partnering with clients to understand their pain points and risk areas. Our consultants work closely with your team to ensure that all relevant daily tasks and activities, reporting, analysis, and maintenance required for GCP QA happen seamlessly while your team is freed up to focus on the bigger-picture goals.
Testimonial
“Working with RegDev, and Sid specifically, has been amazing. Not only is he extremely knowledgeable and experienced in all things GCP, he also understands what startup biotechs need and is able to tailor his services and guidance accordingly.”
— Senior Director, Vendor Outsourcing Precision Medicines Company, San Francisco, CA
