Mark Dockter

Pharmaceutical Industry FDA Warning Letter and Consent Decree Remediation


Mark Dockter is a professional Pharmaceutical Manufacturing Consultant with more than 17 years of regulatory and quality assurance success in the pharmaceutical, biopharmaceutical, 503B compounding and cosmetics manufacturing industries. Leveraging substantial experience ensuring compliance with FDA and other regulatory agencies, he is a valuable advisor for any organization seeking assistance remediating an FDA warning letter or consent decree. His broad areas of expertise include compliance, quality assurance, process development and process validation.

Throughout his career, Mark has held leadership positions with MD Pharma Consulting, LLC, Sombra Cosmetics, and Cardinal Health.

2015 - Present

Pharmaceutical Manufacturing Consultant - MD Pharma Consulting, LLC

MD Pharma Consulting, LLC

  • Assisted several drug manufactures in U.S. Code 21CFR Parts 210 and 211 compliance efforts.

2014 - 2015

Director of Regulatory Affairs and QC/QA

Sombra Cosmetics

  • Brought the company into a state of compliance after receiving an FDA warning letter.
  • Created a quality control unit to ensure all aspects of the business were in compliance with regulations.
  • Saved the company a money by eliminating unnecessary annual testing.

2006 - 2014

Process Validation

Cardinal Health / Catalent / OsoBio / AMRI

  • Contributed to the July-August 2013 PDA Letter, “Important Considerations for Aseptic Processing Validation.”
  • Improved efficiency by implementing the use of Share Point for completed media fill batch records.
  • Cut cost of cleaning validation supplies by 40% by purchasing directly from a manufacturer.

2002 - 2006

Technical Operations / Quality Assurance Documentation

Cardinal Health / Catalent / OsoBio / AMRI

  • Designed a process to transport equipment into sterile areas for sterile compounding.
  • Designed an engineering control (a High Efficiency Particulate Air (HEPA) filtered flexible containment system) for operator safety when weighing highly potent compounds.
  • Won the Cardinal Health Chairman’s award for outstanding performance for work on several projects for global pharmaceutical companies.

I’m Available To Advise On The Following Subjects

Quality Control

Product Development


Process Optimization

Input and advice on a key project

Quality Assurance

Serve as a sounding board and second opinion on a key decision

Ability to review or help create presentations, documents or other materials