Building and sustaining compliance takes more than reactive fixes—it requires systems, documentation, and validation that integrate seamlessly across your operations. Our experts develop and implement compliant frameworks, SOPs, and validation programs designed to ensure data integrity, product quality, and regulatory confidence from the start.
Whether you’re establishing a new QMS, validating critical processes and systems, or addressing specialized regulatory requirements, we tailor our approach to your unique challenges. With experience across FDA, EMA, and international standards, our teams help you maintain control, demonstrate compliance, and drive continuous improvement in every area of your organization.
All of our services are backed by a Total Quality Guarantee.
Design and implement robust QMS and documentation frameworks that support sustainable compliance and operational efficiency.
Prove consistency, reliability, and accuracy through lifecycle process, method, and computer system validation.
Access deep expertise in 503B, EU MDR, and other niche regulatory areas that demand precision and experience.
Establish a strong foundation for compliance and operational excellence with quality systems built to scale. Our experts design, implement, and optimize QMS frameworks tailored to your organization’s structure, processes, and regulatory obligations. From system architecture to clear, compliant documentation, we help you create the infrastructure and procedures that ensure consistent quality performance and long-term sustainability.
Demonstrate control, consistency, and reliability across every process, system, and analytical method. Our validation experts apply risk-based, lifecycle approaches that align with FDA and global regulatory expectations to ensure your operations meet the highest standards of quality and data integrity. From process and computer system validation to analytical method qualification, we help you prove performance and maintain compliance with confidence.
Access targeted expertise for complex regulatory and operational challenges. Our specialized services support organizations facing unique compliance demands—from 503B outsourcing facility oversight and EU MDR transitions to expert witness testimony and customized training. Each engagement is led by professionals with deep, hands-on experience to help you navigate evolving regulations, mitigate risk, and build lasting organizational capability.
Learn how The FDA Group deployed its staff augmentation model to support a multinational pharmaceutical company's QMS remediation efforts. This project principally included deviation and CAPA backlog activities, significant corrective and preventive remediation throughout the quality system, and extended support to assist in staff onboarding, training, and maintaining the continuity of improvements made across the QMS. The FDA Group accomplished its goal of eliminating all backlogs on time and under budget.
Learn how The FDA Group partnered with a large clinical service company to manage its QMS remediation efforts and fulfill long-term staffing assignments for two vital roles in the management of the company’s quality and pharmacovigilance functions. This case study demonstrates the value of our convenient, cost-effective staff augmentation model as a means of circumventing the administrative costs and burdens of traditional hiring.
