Regulatory GMP Compliance

Advice about the industry, from industry people.

Trust is your most valuable asset. That’s why our Risk Mitigation and Regulatory Compliance Management team is ready to help you establish trust with regulatory agencies or build it back up again after an issue. Because many of our advisors are former FDA, EMA, and NMPA regulators, we can guide you through sensitive remediation and data integrity audits. And should your biopharmaceutical or medical device operation go global, we can set you up with proactive strategies to build trust along the way.

Additionally, our knowledgeable Agency Readiness Services team helps you submit high-quality dossiers on time and ensures cGMP-compliant facilities are used to gain regulatory success.

Our services include:

  • Auditing: General GxP audits, Good Distribution Practices, quality systems, management controls, FDA-type mock PAIs and inspections, verification audits and effectiveness checks, gap analyses
  • Data Integrity: Directed audits and analysis, subject matter training, procedure development, interviews of staff, internal investigations, fraud evaluation, coordinating efforts with legal counsel
  • Inspection Support: Hosting, front/back room support, mock interviews, readiness assessments, application conformance reviews, review hosting process, site presentations, and tour routes
  • Training: General GxP topics, data integrity, FDA interaction/prep for FDA inspections, and 1:1 mock interviews
  • Technical Writing: SOPs, validation protocols and reports, annual product reviews, FDA correspondence, audit responses, strategic plans, and other technical reports
  • Data Trend Analysis: Collection, review, analysis, and summary reporting
  • Strategic Advisement: Healthcare authority communications/meetings, consent decree remediation and verification activities, warning l/483 responses, preparation for or attendance at FDA meetings

Quality by design

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QbD Publication

Siegfried Schmitt

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