Ms. Sanders’ expertise in European and Australian regulatory strategy and submissions makes her an outstanding resource for our medical device clients, especially those needing to update their CER applications for medical devices and combination products to comply with new EU regulations.
ROCHELLE, Va. (PRWEB) March 21, 2018
NDA Partners Chairman Carl Peck, MD announced today that Daniela Sanders, a medical device expert with extensive experience in EU and Australian regulatory strategy and submissions, has joined the firm as an Expert Consultant. Ms. Sanders’ experience includes strategic planning and the preparation of medical device and combination product applications to gain marketing approval worldwide, including Clinical Evaluation Reports (CERs) for European and Australian products in all classes, implantables, and combination devices. She was formerly Team Leader of Regulatory Affairs and Senior Regulatory Affairs Officer at Cook Medical in Queensland, Australia.
In addition to her medical device experience, Ms. Sanders served as a US Food and Drug Administration (FDA) Drug Safety Evaluator for Cardio-renal drugs in the Office of Drug Safety at the Center for Drug Evaluation and Research (CDER). Prior to this, she was a Project Officer for the implementation of the Australian Pharmaceutical Advisory Council (APAC) National Guidelines for the Continuum of Care of Medicines between Hospital and Community and a Research Clinical Pharmacist for Brisbane Cardiac Consortium-Clinical Support Systems Program (BCC-CSSP) in Queensland, Australia.
According to Dr. David Feigal, NDA Partners’ Medical Device Practice Manager, “Ms. Sanders’ expertise in European and Australian medical device regulatory strategy and submissions, including CER applications for medical devices and combination products, makes her an outstanding resource for our medical device clients, especially those needing to update their CER applications to comply with new EU regulations. We are very pleased to welcome her to NDA Partners and to our Medical Device Practice.”
Ms. Sanders earned her Bachelor of Pharmacy degree with Honors from the University of Nottingham, United Kingdom, and post-graduate certificate in Clinical Pharmacy from London University. She is a Licentiate of the Royal Society of Chemistry, Greenwich University in London, England.
About NDA Partners
NDA Partners is a life sciences management consulting firm focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; 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 management of client product development programs.
Earle Martin, Chief Executive Officer