Mel Dong, MD, PhD

Mel Dong, MD, PhD

Dr. Dong was a former regulatory reviewer at the U.S. Food and Drug Administration (FDA) responsible for premarket clearance of submissions by regulated industries as well as a member of FDA field inspection team. He has participated in numerous site inspections. He is also experienced in designing, conducting, analyzing, and reviewing preclinical experiments and clinical trials for premarket approval and postmarket surveillance. With nearly 20 years of experience in the U.S., Dr. Dong came back to China in 2004. He has developed a large client base in the Asian Pacific Region and served product development and OEM needs of both local and international companies. 


Professional services provided by Dr. Dong mainly include:

  • GMP/QSR/GLP/GCP compliance consultation, strategy and gap analyses

  • Pre-approval and other GMP regulatory audits and mock inspections

  • Third party monitor of GLP and GCP studies

  • Development of practical GxP training courses and workshops

  • Validation of facilities, equipment, and analytical methods

  • Development of SOP and other GxP documentation systems

  • Consultation meetings with both Chinese and U.S. FDAs

  • Preparation and review of regulatory documentations: DMFs, INDs, ANDAs, NDAs, BLAs, 510(K)s, PMAs, and annual reports


Regulatory courses instructed by Dr. Dong in English and Chinese currently include:

  • cGMPs: Interpretation and Application for Dosage Forms

  • cGMPs: Interpretation and Application for APIs

  • cGMPs: Validation and Qualification

  • cGMPs: Laboratory Controls

  • cGMPs: Batch Records Review and Investigations

  • cGMPs: GMP Compliance Auditing

  • cGMPs: GMP Compliance Auditing for Sterile Pharmaceuticals

  • FDA Regulations on New and Generic Drugs

  • FDA Regulations on APIs

  • FDA Regulations on GLP and Site Inspection

  • FDA Regulations on GCP and Site Inspection

  • FDA Regulations on Human Drugs (Fudan course)

  • Basic Principles and Applications of Pharmacoeconomics (Fudan Course)

Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

Stephen Casey, MBA
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Peter Damsbo, MD

Richard Paul, MD

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, PhD

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Christopher Kotsopulos, MS

Doug Muchmore, MD

Frances Mielach, Ph.D, RPh.

Gabrielle Wiederkehr, MSc

Joshua Sharlin, Ph.D

 

EU Regulatory

Michael Trautmann, MD

 

Clinical Operations/Project Management

Chris Yun

Diane Paul, MS, RN

Gabrielle Wiederkehr, MSc

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Lynn Schaich

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RPh.

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC and Clinical Supplies Management

Knut Zellerhoff, Ph.D

Robert Kaster, Rph., ASQ-CQA

 

Medical Device

Christopher Kotsopulos, MS

Rob Walsh, MD

 

QA/QC

Christopher Kotsopulos, MS

Joshua Sharlin, Ph.D

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Lynn Schaich

Robert Kaster, Rph., ASQ-CQA

 

Medical Writing/Regulatory Submissions

Marijke Adams PharmD, Ph.D

Peggy Hagerty

Russ Neubauer, Ph.D

Sandor Bernath, PhD, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

 

Business Strategy & Management Support

Lisa Jansa, MBA

Stephen Casey, MBA

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA