FDA Quality and Regulatory Consultants (FDAQRC) announces expansion of Current Good Manufacturing Practices (cGMP)

In our continued efforts to establish long-term partnership with our clients, FDAQRC is expanding in Current Good Manufacturing Practices (cGMP) by including a broad range of comprehensive quality and regulatory compliance services. This improved suite of services includes training, internal and external audits, system risk-based quality assessments, regulatory inspection readiness, and Quality Systems remediation. 


To facilitate this expansion, FDAQRC hired James “Jim” Darnell to serve as the director of Remediation. Darnell is a Quality and Compliance Subject Matter Expert. “Jim’s expertise extends internationally, said President of FDAQRC, Christopher Rush. “He has served in various leadership roles in life science companies and is a known subject matter expert for the industry specializing in development and remediation.”


Darnell joins FDAQRC’s staff and global consultant network at a pivotal time. “I am excited to begin this program with FDAQRC. We pride ourselves in providing custom value-added solutions and with this additional service offering, FDAQRC can oversee the entire product lifecycle – from development through commercialization.”


FDAQRC’s staff and global consultant network is comprised of former FDA employees, European Medical professionals, QA certified experts, and industry leaders who will guide you during your quality and compliance projects. Additionally, we assign a dedicated project manager to each project to provide full oversight and tailored capabilities.


To find out more about how FDAQRC can support your organization’s need to achieve and remain in a continuous state of cGMP compliance, visit FDAQRC.com.

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