We perform detailed assessments of your existing quality system, identify current and potential problems, recommend corrective and preventive actions, and work closely with your staff to implement these improvements to your quality system. We analyze FDA’s inspection history using predictive language to determine your risk for future inspections and can assist you with all aspects of compliance, including but not limited to, GMP, GCP, and GLP.

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • Recruiting Team External Search
  • In-House Subject Matter Experts
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management For Client
  • Total Quality Guarantee

GMP Auditing

We bring direct experience in pharmaceutical, biologic, and medical device and diagnostic manufacturing to help you with GMP quality assurance.

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GCP Auditing

Our team conducts study-specific GCP audits of protocols, investigator sites, trial master files, pharmacovigilance, databases, and reports for a wide variety of clinical studies all over the world.

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GLP Auditing

Our quality assurance personnel provide comprehensive auditing services for all types of laboratories.

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Vendor/Supplier Auditing

Our certified, experienced auditors plan, schedule, and execute vendor/supplier quality management audits to identify areas of conformance and nonconformance with applicable global regulations.

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Pharmacovigilance Auditing

Assess and maintain compliance with your pharmacovigilance program.

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Data Integrity Auditing

Our data integrity, validation, and quality experts perform comprehensive computer systems and data assessments to ensure your system requirements are fully met and adequately documented.

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MDSAP Auditing

Our experienced auditing professionals can assess your current processes against the MDSAP requirements and help you identify and remediate key areas while training staff to maintain compliance under MDSAP.

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Concerned your quality system doesn't reflect FDA expectations?

We'll pair you with former FDA and industry professionals who have extensive knowledge of FDA's current inspection techniques and expectations that go beyond the words of regulation. Through mock FDA audits, remediation support, and resourcing for your quality system, you can make the appropriate adjustments to meet all FDA regulations.

  • No significant FDA-483 observations following inspections
  • No FDA warning letters
  • No delays in approval of PMA’s or NDA’s because of quality system deficiencies
  • No mention of your company name in FDA Enforcement Reports

Contact us to learn more about our auditing services.