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Our Team
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.
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.
Federal Register Documents from Food and Drug Administration
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsThe Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. This meeting will be held to discuss the Strain Selection for the Influenza Virus Vaccines […]
- Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective DateAs required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020. The new effective date is October 6, 2023.
- Proposal To Withdraw Approval of MAKENA; HearingThe Food and Drug Administration (FDA, Agency, or we) has granted a hearing on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw approval of MAKENA (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL), once weekly), new drug application (NDA) 021945, held by Covis Pharma Group/ Covis Pharma GmbH (Covis). This notice […]
- Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing AidsThe Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with the new OTC category; repeal the conditions […]
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.'' This guidance document is intended to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. […]
- Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Hydrogen Peroxide- Based Contact Lens Care Products: Consumer Labeling Recommendations-- Premarket Notification (510(k)) Submissions.'' FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. […]
- Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.'' This guidance is intended to update and provide clarity on the replacement reagent and instrument family policy for manufacturers of in vitro diagnostic devices and FDA staff […]
- AbbVie Inc., et al.; Withdrawal of Approval of 30 New Drug ApplicationsThe Food and Drug Administration (FDA or Agency) is withdrawing approval of 30 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
- Soliciting Public Comment on Appendix A of the Food and Drug Administration's July 2018 Guidance Entitled “Abbreviated New Drug Application Submissions-Amendments To Abbreviated New Drug Applications Under Generic Drug User Fee Amendments;” Notice; Establishment of a Public Docket; Request for CommentsThe Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit comments on the content of Appendix A in the July 2018 guidance for industry entitled ``ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA'' (ANDA Amendments Guidance). We are soliciting comments on the content of Appendix A. […]
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Ovines (Revision 1); Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry GFI #96 (VICH GL13(R1)) entitled ``Effectiveness of Anthelmintics: Specific Recommendations for Ovines (Revision 1).'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal […]