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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
- Patient Engagement Advisory Committee; Notice of MeetingThe Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting […]
- Modified Risk Tobacco Product Application: Application for Copenhagen® Snuff Fine Cut, a Loose Moist Snuff Tobacco Product Submitted by U.S. Smokeless Tobacco Company LLCThe Food and Drug Administration (FDA) is announcing the availability for public comment of a modified risk tobacco product application (MRTPA) for Copenhagen[supreg] Snuff Fine Cut, a loose moist snuff tobacco product submitted by U.S. Smokeless Tobacco Co. LLC.
- Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management 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 Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is […]
- Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for Food and Drug Administration Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to the Food and Drug Administration; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.'' The draft guidance provides the current thinking of FDA's Center for […]
- Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Draft Guidance for Industry; AvailabilityThe Food and Drug Administration FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.'' This draft guidance intends to clarify questions relating to product identifiers that are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), […]
- Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; 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 ``Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.'' The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have […]
- Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3The Food and Drug Administration (FDA or we) is amending the food additive regulation for vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications. We are taking this action […]
- Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.'' This guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be grandfathered […]
- Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Product Identifier Requirements Under the Drug Supply Chain Security Act-- Compliance Policy.'' This guidance describes FDA's intention with regard to enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring manufacturers to begin affixing or […]
- Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; CorrectionThe Food and Drug Administration is correcting a notice entitled ``Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of September 11, 2018. The document announced a draft guidance that provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated […]