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Lamont M Fulton

Principal Consultant, REGULATORY DIRECTION

Mr. Lamont Michael Fulton is President of Regulatory Direction LLc and has over Forty years of Pharmaceutical experience (26 in regulatory affairs CMC).He has had roles as both Manager and Director of Chemistry Manufacturing and Controls (CMC) Regulatory and labeling at both Branded (Merck, SmithKline, Wyeth) and Generic drugs firm (Mylan). Prior to working as the leader to regulatory affairs departments, Mr. Fulton worked at the FDA as a Chemist reviewer in the center for drugs. While at the FDA, He also worked as an Analyst in the office of regulatory affairs and international office of policy, dealing with FDA/ICH regulations and guidance for global initiatives.

Mr. Fulton's past experience in government and industry, including his current role as senior consultant, has allowed him the opportunity to develop relationship with various CMC partners (Pfizer, Johnson and Johnson, Bristol Myers Squibb, etc.). It has also afforded his consultancy the chance to assist and manage other multidisciplinary teams achieve approval for dozens of NDA's, ANDA's to the FDA, as well as provide help with several successful international drug applications to the EMEA, MHLW and ROW. The blended years of both pharmaceutical quality and regulatory affairs has provided Mr. Fulton with a perspective to determine appropriate filing strategy and provide regulatory impact of changes in post Marketing products.

Mr. Fulton has BA degree in Chemistry from Cheyney University of Pennsylvania; where he studied under Dr.Taylor on the nature of terpenes and its various derivative. Certificate of Pharmaceutical training from University of Maryland school of Pharmacy / FDA program. Mr. Fulton's affiliations included; GPhA (Generic Pharmaceutical Association), ACS American chemical society) RAP (Regulatory Affairs Professional society), PDA (Parenteral Drug Association); Sigma Xi.



  •  Friday, January 25, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
QbD Development Process Evaluating Critical Steps

The topic of discussion focuses on practical and realistic approaches to implementation QbD, and how to apply QbD .

  •  Friday, February 15, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
505(B)(2) APPLICATIONs,Standards for Approval

The submission of a 505(b)(2) applications must be based on the presentation of required scientific evidence of safety and equivalency studies,





  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
QbD Development Process Evaluating Critical Steps

The topic of discussion focuses on practical and realistic approaches to implementation QbD, and how to apply QbD .

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
505(B)(2) APPLICATIONs,Standards for Approval

The submission of a 505(b)(2) applications must be based on the presentation of required scientific evidence of safety and equivalency studies,