Compliance

Becker Compliance provides Quality System and Compliance consulting services that are strategically designed to provide efficient, practical, and compliant solutions for FDA-regulated industries. We work to develop or enhance Quality Systems solutions to meet current industry standards and regulatory requirements, throughout the total product lifecycle.

Our practice is led by Elaine C. Messa and Maxine K. Fritz, both recognized as leaders in FDA compliance. With over 45 years of combined FDA and industry experience, we have worked with more than 450 leading pharmaceutical, biologics, in vitro diagnostic (IVD), combination product and medical device firms in the United States and worldwide.
Becker™ Compliance Services:
  • Development and implementation of Quality Systems
  • cGMP and QSR compliance audits
  • FDA Inspection readiness training and mock audits
  • Development and implementation of corrective action programs
  • FDA enforcement action remediation, including Form 483s, Warning Letters, Recalls, Import Detentions, Consent Decrees, and License Revocations
  • Management of communications with FDA and other regulatory agencies
  • Due diligence assessments to identify regulatory risks for acquisition targets
  • Compliance activities, including Corporate Integrity Agreements (CIAs), Interim Compliance Officer, and Independent Review Organization Assistance
  • Training on Quality Systems, cGMP/QSR, FDA readiness and other technical fields