Mock FDA Audits

Mock Audit services are offered by a collaboration of experienced, independently successful CGMP Quality consultants.  The team assembles the requisite skill sets for the particular job and can handle the largest facility audit or the start-up who wants a quick review prior to the Agency visit.

Identify the deficiencies in your Quality CGMP in time to work on them before the FDA arrives.

This team provides a comprehensive review and audit process to assist manufacturers of Pharmaceuticals, Bio-tech, Medical devices, Oral dose, Inhalation and Nanotechnology related companies to meet regulatory standards in pre-approval (PAI) and other licensing inspections for US and International compliance.

The team is comprised of 4 experts that represent over 100 years of experience in their related fields.

Anne Marie Dixon

Over 35 years of experience in cleanroom design, gowning maintenance, and qualification; controlled environment management; GMP compliance and training; and contamination control.

J. Scott Kemp

Over 40 years of experience in facility and basis of design (BOD) for pharmaceutical and biotechnology plants; HVAC and WFI systems design, utilities and process equipment validations and PM programs; expert operations management.

Scott Sutton, Ph.D.

Over 30 years in contamination control measures (sterile, aseptic and non-sterile manufacturing); environmental monitoring; sanitizers/disinfectants qualification; GMP compliance and training; and QC microbiology laboratory testing and operations.

Robert Zeid

Over 27 years in pharmaceutical development with a focus in biopharmaceutical regulatory affairs; quality systems auditor; analytical methods development and validation; comparability; and change control.

This team is experienced in reviewing all production and support facilities and utilities, validation, testing and all finished product documentation.

Our expert comprehensive review balances the time on-site, report of findings, and if needed, corrective action SOLUTIONS that will assist the client is a successful inspection.  This cost-effective direct approach helps our clients experience a successful inspection and license.    By using a structured review of the production facilities, utilities, validation, testing and other manufacturing documentation, the PAI Team makes the most efficient use of on-site auditing, report writing, and if requested, corrective actions.

Take advantage of the extraordinary breadth of skills offered by this experienced team with seasoned, proven advice.  In addition to the mock audit and PAI preparation services, this team is available for:

  • Regulatory and cGMP Compliant Document Review and Preparation.
    Whether it’s a regulatory submission, environmental monitoring program, or cleaning validation protocol, the PAI Team can provide quick, expert review of your program documents to ensure the most current regulatory compliance is applied.  Years of personal experience ensure that documents submitted to the FDA are of the utmost quality — helping to improve the chances for a smooth and rapid product approval.
  • Audits and Reviews.
    Leveraging our extensive experience in compliance, science, and technology, our team can perform a wide variety of audits and reviews of good practices for drug and device manufacturing, laboratory management, marketing and promotion, and more.
  • Due Diligence Audits
    In addition to working directly with pharmaceutical, biologic, medical device, and dietary supplement companies, the PAI Team delivers support to venture capital firms or other companies seeking acquisition of technology, products in all phases, facilities, businesses, and other assets.  The PAI Team can provide cost-effective reviews of program compliance and milestones.

Over 30 years in contamination control measures; sanitizers/disinfectants qualification; GMP training; and QC microbiology laboratory testing and operations