Ms. Richter’s extensive experience in regulatory affairs and quality in the pharmaceutical industry in both the US and EU will provide an outstanding resource to our drug development clients.
ROCHELLE, Va. (PRWEB) February 12, 2020
NDA Partners Chairman Carl Peck, MD, announced today that Monika Richter, a senior regulatory affairs and quality executive with more than 20 years of international experience in the pharmaceutical industry, has joined the firm as an Expert Consultant.
Prior to joining NDA Partners, Ms. Richter served in several senior executive positions at Boehringer Ingelheim, including Senior Vice President of Global Regulatory Affairs and Vice President of Global Quality Management Medicine. During her tenure as Senior Vice President of Global Regulatory Affairs, she successfully directed and oversaw the development and execution of regulatory strategies for development programs, approved products, and respective filings across all therapeutic areas to Health Authorities worldwide, including the US Food and Drug Administration (FDA) and European Medicines Authority (EMA).
Ms. Richter has also worked at both the United States and German operating units and global headquarters of Boehringer Ingelheim, where she directed interactions with the FDA, the Federal Institute for Drugs and Medical Devices (BfArM)/Paul-Ehrlich-Institut (PEI), and European Authorities. Additionally, under her leadership as head of Global Quality Management, the company’s Quality Management System was further developed, including a simplified SOP – System and integrated quality strategy.
In her early career, Ms. Richter served in regulatory affairs leadership positions at Fresenius Medical Care (Bad Homburg, Germany), Merck Generika, and Desitin Arzneimittel GmbH.
According to Dr. Carl Peck, “Ms. Richter’s extensive experience in regulatory affairs and quality in the pharmaceutical industry in both the US and EU will provide an outstanding resource to our drug development clients. We are very pleased to welcome her to NDA Partners.”
Ms. Richter earned a Diploma in Microbiology, Biochemistry, and Botany from the University of Hamburg (Hamburg, Germany) and a Vordiplom in Biology from the University of Oldenburg (Oldenburg, Germany).
About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Earle Martin, Chief Executive Officer