Mark Dockter

Pharmaceutical Industry 483 Observation, FDA Warning Letter and Consent Decree Remediation

ADVISOR BIOGRAPHY

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.

July 2015 - Present

President, MD Pharma Consulting, LLC

MD Pharma Consulting, LLC

  • Over the past 17+ years, I successfully completed projects for Merck, Wyeth, Pfizer, Novartis, Eli Lilly, GlaxoSmithKline, Boehringer Ingelheim, Medimmune, Millennium, UCB Pharma, Walter Reed Army Institute of Research and a host of smaller pharma/biopharma, 503b and cosmetic companies.
  • As a Consultant I have successfully aided several drug manufactures to reach 21 CFR Part 210 and 211 compliance goals. These efforts included remediation of 483 Observations, Warning Letters and Consent Decrees.

I’m Available To Advise On The Following Subjects

Quality Control

Product Development

FDA

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