Our Team

Dr. Kulinets
Dr. KulinetsIrina Kulinets, PhD, RAC, CQE
Dr. Kulinets is a well known Regulatory and Clinical Affairs and Quality Assurance Consultant / Expert / Executive with more than 20 years of success in the global medical device and biotech industries and regulatory bodies. She worked at such companies as Johnson & Johnson; Boston Scientific; Cynosure, Inc.; Anika Therapeutics, Inc.; BioSphere Medical, and others.

Her work as an executive and consultant resulted in defining, developing and implementing worldwide regulatory strategies, clinical strategies and quality initiatives to support corporate vision, mission and business objectives handling domestic and international medical device, pharmaceutical and biologic regulatory filings and product registrations. She was involved in designs and execution of all phases of pre-approval clinical trials and field evaluation (post-marketing) clinical studies, as well as in developing, implementation and maintenance of effective and compliant state-of-the-art quality systems.

Dr. Kulinets is a lecturer and the faculty director of the Master’s in Regulatory Affairs for Drugs, Biologics, and Medical Devices degree program at Northeastern University. She holds RAC (RAPS) certification and is also FDA Accredited Person Inspector, Certified Third Party FDA 510K Reviewer, Notified Body Design Dossier Reviewer, Lead Notified Body Medical Auditor, ASQ Certified Six Sigma Black Belt, ASQ Certified Quality Engineer (CQE), and Certified ISO 13485:2003/CMDR Lead Assessor. Dr. Kulinets is a member of the Regulatory Affairs Professional Society and the Association of Clinical Research Professionals, a senior member of the American Society of Quality, and a council member of the Life Science Division at Gerson Lehrman Group.

Theodore A. Olsson
Theodore A. Olsson
Mr. Olsson is a life science and business development professional with more than 35 years’ experience successfully managing business relationships, building organizations and life science service businesses. He has served as a Vice President Corporate Development with a specialty pharmaceutical company, as Vice President with an international contract research organization, as Senior Consultant and Business Unit Manager with Arthur D. Little, Inc. and managed several laboratory service businesses. In these roles he has international experience leading operations in US, UK, Finland, and Sweden, as well as leading contracted services with the US government. Mr. Olsson has a Bachelor of Science degree in Biochemistry from University of Massachusetts, Amherst. As a consultant, Mr. Olsson provides marketing, business development and strategic planning services. As a Director of Business Development with clinical research organizations, he successfully managed long-term relationships involving all phases of clinical trial research for client medical device, pharmaceutical and biotechnology companies. He has supported and strengthened the relationships between service provider and sponsor clinical research teams as they achieved success with complex programs for medical device, biologic/device combination products, rare disease therapeutics, oncology, cardiovascular and infectious disease therapeutics.