News & Events

The Quality Management System (QMS) Pitfalls of Medical Device Entrepreneurship
Med Tech Outlook (August 13, 2019)
The Key to Successful Software as a Medical Device (SaMD) Implementation
Med Tech Outlook (August 13, 2019)
Five Fundamental Principles for Optimal Medical Product Development
Med Tech Outlook (August 13, 2019)
Senior Regulatory Affairs Executive, Gregory T. Bates, DVM, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (July 31, 2019)
Former OrthoLogic Quality Assurance Director, Donna Hartzfeld, PhD, Joins NDA Partners
Rochelle, Virginia (July 24, 2019)
Head of NDA Partners wins Business Worldwide Magazine's CEO Award for Innovation in Life Sciences Consultancy
London (July 8, 2019)
New consultancy service aids growth of pharma disruptors
London (June 16, 2019)
Andrea Miller, Quality Assurance Expert, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (June 12, 2019)
Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation
British Journal of Clinical Pharmacology (June 7, 2019)
Former FDA Associate Director, Office of Epidemiology & Biostatistics (CDER), William Fairweather, PhD, PSTAT, Joins NDA Partners
Rochelle, Virginia (May 29, 2019)
Leo Kawai, PhD, Distinguished Translational Drug Research and Development Expert, Joins NDA Partners
Rochelle, Virginia (May 22, 2019)
Johannes N. van den Anker, MD, PhD, Prominent Neonatal and Pediatric Clinical Pharmacologist, Joins NDA Partners
Rochelle, Virginia (May 15, 2019)
Former Vice President, Biometrics at GRAIL, Inc., Tara Maddala, PhD, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (April 24, 2019)
Dr. Constance Benson, Internationally Recognized HIV and TB Researcher and Clinician, Joins NDA Partners
Rochelle, Virginia (April 10, 2019)
NDA Partners Awarded the Best Life Sciences Management & Contract Development Organisation 2019 – USA by Global Health & Pharma
Rochelle, Virginia (March 27, 2019)
Mark Gonitzke, RPh, MBA, Former FDA Regulatory Reviewer, Office of Generic Drugs, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (March 20, 2019)
Dr. Francesca Joseph, Former FDA Medical Officer, Office of Orphan Products Development, Joins NDA Partners
Rochelle, Virginia (February 13, 2019)
NDA Partners Appoints Deb Koeneman as Partner in the Firm
Rochelle, Virginia (December 19, 2018)
NDA Partners Expert Consultant Vinod Shah, PhD, Receives AAPS Award for Global Leadership
Rochelle, Virginia (December 12, 2018)
Mary Crivellone, PhD, Former Director of Global Laboratory Integration at USP, Joins NDA Partners as an Expert Consultant
Rochelle, Virginia (December 5, 2018)
Barb Geiger, Former Executive Vice President of Clinical Development and Head of Global Oncology at Clinipace Inc., Joins NDA Partners as an Expert Consultant
Rochelle, Virginia (November 7, 2018)
NDA Partners – A Life Sciences Management Consulting Firm Focused On Providing Product Development And Regulatory Services
Rochelle, Virginia (October 29, 2018)
Carl Peck, MD, Chairman of NDA Partners LLC, to present lecture for Gerhard Levy Distinguished Lectureship Series in Pharmaceutical Sciences
Rochelle, Virginia (October 3, 2018)
B. Melina Cimler, PhD, Former Senior Vice President of Regulatory & Quality at Adaptive Biotechnologies, Joins NDA Partners
Rochelle, Virginia (September 26, 2018)
Lauren Bronich-Hall, Senior Quality Management Expert, Joins NDA Partners as an Expert Consultant
Rochelle, Virginia (September 12, 2018)
Steven Shafer, MD, Highly-Regarded Anesthesiologist and Clinical Pharmacology Expert, Joins NDA Partners
Rochelle, Virginia (July 25, 2018)
Scott Brittain, PhD, Pharmacokinetic/Pharmacodynamic Modeling and Simulation Expert, Joins NDA Partners
Rochelle, Virginia (July 18, 2018)
Jason Schense, PhD, Former Chief Technology Officer, Kuros Biosciences AG, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (July 11, 2018)
Bruce Green, D.Ph, Internationally Recognized Pharmacometrics Expert, Joins NDA Partners
Rochelle, Virginia (May 23, 2018)
Yong Fan, MD, Former FDA Senior Product Quality Reviewer, Office of Tissues and Advanced Therapies, Joins NDA Partners
Rochelle, Virginia (May 16, 2018)
Mark D. Weiss, Former Purdue Pharma Principal Scientific Writer, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (May 3, 2018)
NDA Partners Appoints Alberto Gutierrez, PhD to Partner
Rochelle, Virginia (April 25, 2018)
Dennis M. Fisher, MD, a Highly Regarded Clinical Pharmacology and Pharmacodynamics Expert, Joins NDA Partners
Rochelle, Virginia (April 18, 2018)
Alexander A. Vinks, PharmD, PhD, FCP, Director, Division of Clinical Pharmacology, Cincinnati Children’s Hospital Medical Center, Joins NDA Partners
Rochelle, Virginia (April 4, 2018)
Daniela Sanders, Medical Device Expert and Former FDA Drug Safety Evaluator, Joins NDA Partners
Rochelle, Virginia (March 21, 2018)
Former FDA and IQVIA Director, Lana Pauls, MPH, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (March 14, 2018)
Former XenoPort Chief Medical Officer, Richard Kim, MD, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (February 21, 2018)
Former FDA Director Eric B. Sheinin, PhD, joins NDA Partners as Expert Consultant
Rochelle, Virginia (February 14, 2018)
Former FDA Director, Alberto Gutierrez, PhD, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (February 7, 2018)
NDA Partners Introduces Quantitative Drug Development Strategies Practice
Rochelle, Virginia (January 10, 2018)
NDA Partners Expert Consultant Vinod Shah, PhD, receives AAPS Distinguished Pharmaceutical Scientist Award
Rochelle, Virginia (December 5, 2017)
NDA Partners Appoints Roberta Druyor-Sanchez as Partner
Rochelle, Virginia (October 25, 2017)
John W. Sheets Jr., former FDA Director of the Office of Device Evaluation, joins NDA Partners as Expert Consultant
Rochelle, Virginia (August 23, 2017)
Former VP of Clinical Pharmacology at Nektar Therapeutics, Michael A. Eldon, PhD, FCP, joins NDA Partners as Expert Consultant
Rochelle, Virginia (August 7, 2017)
Former Associate Director of Product Development R&D at Allergan, Melissa Kirkegaard, joins NDA Partners as Expert Consultant
Rochelle, Virginia (June 26, 2017)
NDA Partners Announces Collaboration Agreement with Qualiminds Corporate Services of Mumbai India
Rochelle, Virginia (June 13, 2017)
Former Vice President of Development Operations at XenoPort, Sami Karaborni, PhD, joins NDA Partners as Expert Consultant
Rochelle, Virginia (June 5, 2017)
Former CEO of Eurofins Advantar Laboratories, Richard Kenley, PhD, joins NDA Partners as Expert Consultant
Rochelle, Virginia (May 17, 2017)
Former Director of FDA Division of Biostatistics, Gregory Campbell, PhD, joins NDA Partners as Expert Consultant
Rochelle, Virginia (April 17, 2017)
Vinod Shah, PhD, Former Senior Research Scientist in FDA Office of Pharmaceutical Sciences, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (April 3, 2017)
Greg Coulter, PhD, CMC Pharmaceutical Development Executive, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (March 2, 2017)
Dr. Daniel Spyker, Former FDA acting Deputy Division Director of Cardiovascular, Respiratory, and Neurological Devices, Joins NDA Partners
Rochelle, Virginia (February 22, 2017)
Dr. Deborah Wenkert Pediatrics Expert and Former Amgen Clinical Research Medical Director, Joins NDA Partners
Rochelle, Virginia (February 1, 2017)
Dr. Steven Brooks, former FDA Medical Officer, Peripheral Vascular Device Branch, Office of Device Evaluation, Joins NDA Partners
Rochelle, Virginia (December 27, 2016)
Carl Peck, MD, Chairman of NDA Partners LLC, to receive ASCPT Sheiner–Beal Pharmacometrics Award
Rochelle, Virginia (October 24, 2016)
NDA Partners to Present Data Integrity Workshop for India Pharma Exporters
Rochelle, Virginia (October 5, 2016)
Mitchell Shein, Former FDA Deputy Director, Division of Cardiovascular Devices, Joins NDA Partners
Rochelle, Virginia (September 26, 2016)
NDA Partners Appoints Roger Williams, MD, to Partner in the Firm
Rochelle, Virginia (July 18, 2016)
NDA Partners Introduces Biologics Consulting Practice
Rochelle, Virginia (July 11, 2016)
NDA Partners Introduces Medical Device Expert Consulting Practice
Rochelle, Virginia (May 5, 2016)
Jon Clark, Former Vice President of USP, Joins NDA Partners as Expert Consultant
Rochelle, Virginia (April 27, 2016)
NDA Partners Forms Specialized CMC Practice
Rochelle, Virginia (March 17, 2016)
Philip Goliber, PhD, Appointed Partner in Product Development and Regulatory Strategy Consulting Firm NDA Partners
Rochelle, Virginia (February 29, 2016)