Evaluate, improve, and maintain all areas of your quality system with the help of experienced quality professionals.

Managing quality effectively in an FDA-regulated environment requires a system to control, monitor, and verify all activities and processes related to product safety. Our staff augmentation services pair you with the right professionals to enhance your quality system through a customized evaluation and improvement program tailored to your specific needs.

Our large staff of 600+ specialists worldwide, 75+ of whom are former FDA, bring firsthand experience and a thorough understanding of FDA and global compliance requirements to assess your current quality system, identify gaps, and implement the improvements necessary to maintain compliance within the increasingly complex, global regulatory environment.

What is Staff Augmentation?

Our staff augmentation service provides exclusive access to a diverse talent pool of professionals capable of addressing virtually any need pertaining to quality within the pharmaceutical, biotechnology, and medical device industries.

How we can help

  • Preparing policies, quality standards, and SOPs
  • Reviewing batch records
  • Planning, conducting, and/or managing remediation projects
  • Performing root cause investigations, progressing Corrective and Preventive Actions (CAPA)
  • Performing GxP audits
  • Performing MDSAP audits
  • Planning and conducting mock FDA inspections
  • Performing global supplier and vendor audits
  • Identifying and closing data integrity gaps in a GxP environment
  • Reviewing and improving management controls
  • Identifying and assuring the ā€œcā€ in cGMP: melding industry standards with ever-changing regulations
  • Enhancing management controls
  • Conducting oversight programs for senior leadership
  • Reviewing and improving training resources
  • Executing site-wide organizational improvement plans

The benefits of working with The FDA Group 

We recognize the challenges of developing and managing an effective quality system under the watchful eye of regulators. Our quality system resourcing professionals draw on years of experience and highly specialized skills to ensure objective, accurate, and actionable recommendations are made each step of the way.

Our proprietary talent selection process brings together a diverse array of skill sets, experience, and expertise to offer a truly unique opportunity for companies interested in receiving personal and professional attention.

Contact The FDA Group today to learn more about our Staff Augmentation services.