Donawa Lifescience Consulting

Donawa Consulting includes former FDA officials, experienced quality system and GMP auditors, senior clinical study personnel, senior regulatory and environmental affairs professionals, engineers, and computer system validation technical and regulatory experts.

Thus, we not only understand medical technology regulatory and environmental requirements, but also the most pragmatic way of meeting them. This allows our clients to reach not only their regulatory objectives, but their business objectives as well.

The Donawa Lifescience Consulting team provides medical technology companies with the highest level of expert advice and hands-on assistance in complying with US and European regulatory, quality system, GMP and clinical data requirements.

MARIA DONAWA, MD
PRESIDENT

Dr. Maria E. Donawa is a physician and pathologist, and former official of the US FDA Center for Devices and Radiological Health. Click here to learn more.

ROGER GRAY, BSc, CEng, MIMechE
VP, QUALITY AND REGULATORY

Based in the UK, Roger Gray has over 30 years' experience in the Medical Device industry, specializing in European & US regulatory and quality management requirements. He was Chairman of the Association of British Healthcare Industries (ABHI) Technical Committee and was closely involved with the development of the Medical Devices Directive during its formative stages. Click here to learn more.

BEATRICE JANIN JACQUAT, MD
MEDICAL AFFAIRS ASSOCIATE

Dr. Janin Jacquat has more than fifteen years experience in clinical and epidemiological research, providing medical and statistical direction and support for companies in a number of medical fields. Her experience embraces: designing, developing, managing and reporting of Phase I to Phase III clinical trials and epidemiological studies; managing related issues such as negotiation with suppliers, outsourcing and budget control; negotiation with FDA, EMEA, WHO, and country-specific health authorities; and managing clinical trial project teams, including human resource issues and training. Click here to learn more.

MOSHE VARDI, MD

CLINICAL ADVISOR

Dr. Moshe Vardi is a physician specializing in Internal Medicine, an industrial engineer, and the author of several recently-published systematic reviews and meta-analyses. He serves as a senior physician in a university-affiliated hospital in Haifa, Israel, and his scientific work has been published in the Cochrane Library and leading medical journals. Dr. Vardi has worked in the medical device field for over 10 years, in both Medical Director and consultant roles for medical device companies. His systematic reviews of medical literature have served as the basis for regulatory applications, pre-clinical and clinical trial plans, as well as the economic evaluation of medical technologies. Click here to learn more.

CORNELIA CAMARA, MSc
DIRECTOR, DRUG REGULATORY AFFAIRS EU/US

Based in Nyon, Switzerland, near Geneva, Cornelia Camara is a biochemist with more than 13 years of professional experience in the pharmaceutical and the medical device industries. Prior to joining the Donawa team, she held management positions with Ares Serono, Sanofi-Synthélabo and Debiopharm in Switzerland, during which time she was responsible for the development of European and US regulatory submissions. As Regulatory Affairs Manager at Medipol SA, a nanotechnology and medical device consultancy company, her responsibilities included project planning & management, and regulatory training for device start-up companies. Click here to learn more.

DANIELA KARRER, BSc
DIRECTOR, CLINICAL AFFAIRS

Ms Karrer has nearly 20 years’ experience in the health science field, working most recently as Director, Project Management with Covance Clinical Services Ltd. In this position, she was she was responsible for project delivery and financial performance of selected international oncology trials. After graduating from Rome University, Italy with a degree in biological sciences, Ms Karrer worked first within the Italian health service and then with the Serono Group as a research scientist, before moving to Covance as a CRA in 1999. Ms Karrer is responsible for Donawa Lifescience Consulting medical device and pharmaceutical clinical services. Click here to learn more.

YOSSI TAL, PhD

DIRECTOR, BIOSTATISTICS AND DATA MANAGEMENT

Yossi Tal has been working with the life science industry for almost 15 years. He has a Doctorate from Northwestern University, Illinois, USA and was a statistician at the US National Institutes of Health, before forming his own company, based in Israel, providing bio-statistical services for regulatory submissions for both devices and pharmaceuticals. Click here to learn more.

ENZO PASSALIA
QUALITY SYSTEMS AND REGULATORY SPECIALIST

Based in Modena, Italy, Enzo Passalia has over 20 years experience in medical device quality management systems, involving both single-use and complex, high-risk electromedical devices. He is expert in both US FDA and European quality system compliance, including the validation of injection molding, EtO sterilization, and other manufacturing and control processes. Mr. Passalia has also been responsible for managing customer support services, complaint handling, and incident reporting, to meet US and European requirements. Click here to learn more.

BRENDA SEIDMAN, MS, PhD
SENIOR TOXICOLOGY ASSOCIATE

Brenda Seidman is a toxicologist and pharmacologist with more than 20 years of professional experience. She is knowledgeable in the areas of medical devices, combination products, pharmaceuticals and biologics. She worked at the U.S. Food and Drug Administration (FDA), where she was a pharmacology/toxicology reviewer in the Center for Drug and Experimental Research (CDER) specializing in metabolism and endocrine drugs, as well as biologic oncology products. Click here to learn more.

TAMI ABUDI, BSc

SENIOR ASSOCIATE, CLINICAL AFFAIRS

Based in Israel, Tami Abudi has over 15 years of experience in the area of clinical research, having graduated from the Life Sciences faculty of Tel Aviv University in 1994. She began her career as a Senior CRA in a medical device company, then served as Director of Clinical Research at Medinol Ltd., Israel, a leading manufacturer of Class III medical devices. More recently, she has managed the clinical development of a pharmaceutical start-up company. Click here to learn more.

MARK BRAZIER, MSc
COMPUTER SYSTEM VALIDATION AND COMPLIANCE SPECIALIST

Mark Brazier has over 20 years’ experience as a senior manager with international companies in the pharmaceutical and medical device industries. He is accustomed to operating effectively with both senior management and operational staff, and moving seamlessly between high-level program and corporate project activities. Working from the UK, Mr. Brazier has a proven record of success in computer system validation in all areas of the healthcare sector and has spoken and published internationally. Click here to learn more.

ANDY VAUGHAN
ENVIRONMENTAL SYSTEMS SPECIALIST

Andy Vaughan has over 10 years of practical experience in all aspects of environmental affairs management relating to medical devices from a manufacturer's perspective, including compliance with the directives on Waste Electrical and Electronic Equipment (WEEE), the Restriction of Hazardous Substances (RoHS), Energy using Products (EuP) and Batteries. In addition, he has guided a multinational company and its subsidiaries through the steps necessary to achieve ISO 14001 compliance, and is involved with the environmental activities of three European industry associations: ABHI, EUCOMED and COCIR, as well as serving on Working Group 20 of IEC TC62A. Click here to learn more.

FRANCESCA MOZZICATO, RN, BS
SENIOR CLINICAL RESEARCH ASSOCIATE

Ms. Francesca Mozzicato is a licensed nurse and an experienced monitor of clinical studies conducted worldwide in accordance with US requirements. Click here to learn more.

STEVE LIEBERMAN
DONAWA CONSULTING US AGENT / SENIOR QUALITY SYSTEM ASSOCIATE

Mr. Lieberman has over 35 years experience in medical device and pharmaceutical regulatory affairs. He was formerly a Vice President of Quality Assurance and Regulatory Affairs in industry, and prior to that with the U.S. Food and Drug Administration (FDA) where he held various positions in the Office of Compliance of the Center for Devices and Radiological Health. He also served FDA as a field investigator, performing international and domestic inspections of pharmaceutical and medical device manufacturers. Click here to learn more.

ULRIKE BURKHARDT, PhD

CLINICAL RESEARCH ASSOCIATE / LOCAL PROJECT MANAGER

Ulrike Burkhardt is based in Germany and is responsible, on behalf of Donawa Lifescience Consulting for the site management and monitoring of clinical study centers in Germany. Dr. Burkhardt has more than 12 years’ experience in clinical studies, having spent time as a CRA at Covance Clinical Services and ribosepharm GmbH, a subsidiary of ratiopharm GmbH. She has extensive experience managing European multicenter studies, including CRF and protocol design, generation of clinical study reports (CSRs), and monitoring study progress with regard to recruitment, timelines and budget. Click here for further details.

VALENTINA BERRUTI, MSc
SENIOR CLINICAL AND REGULATORY ASSISTANT

Valentina Berruti has more than 6 years’ experience in preparing ethics committee and regulatory authority submissions for both drug and device clinical studies, in addition to supporting clinical monitors (CRAs) and project managers in clinical study management. A graduate of Rome University, she worked first at Pfizer, before moving to work with a small CRO in the Regulatory Approval Department. She then moved to Covance, where she worked for nearly 4 years, performing many CRA-related roles. Her experience spans several therapeutic areas among which are cardiology, oncology, psychiatry and hematology. Click here to learn more.

SARA CATARINOZZI, BA
ADMINISTRATIVE ASSISTANT

Sara Catarinozzi has a B.A. degree in Sociology from York University, U.K. and has worked with Donawa Lifescience Consulting for over 10 years. She manages all administrative matters for the office, but also assists company staff with contacts with clients and other support services. Click here to learn more.

Regulatory References