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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
- Request for Nominations for Voting Members on Public Advisory Panels of the Medical Devices Advisory CommitteeThe Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary of Health and Human Services (the Secretary) […]
- Dermatologic and Ophthalmic Drugs 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 Dermatologic and Ophthalmic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on […]
- Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review VoucherThe Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric […]
- 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 November 6, 2023.
- Antimicrobial Drugs 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 Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
- List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic ActThe Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, […]
- Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' This guidance describes FDA's regulatory and enforcement priorities regarding preparation of beta-lactam oral antibiotic suspension products that appear […]
- Bristol Myers Products Inc.; Proposal To Withdraw Approval of a New Drug Application for Bufferin (Aspirin) Tablets; Opportunity for a HearingThe Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of a new drug application (NDA) for Bufferin (aspirin) tablets, for which Bristol Myers Products Inc., 1350 Liberty Ave., Hillside, NJ 07205 is the last holder of record, and is announcing an opportunity for the […]
- Statement of Organization, Functions, and Delegations of Authority; CorrectionThe Food and Drug Administration (FDA) is correcting a notice entitled ``Statement of Organization, Functions, and Delegations of Authority'' that appeared in the Federal Register of September 28, 2022. The document announced the publication of a reorganization of the Office of Regulatory Affairs (ORA) headquarters and field offices. This Federal Register notice (FRN) contained editorial […]
- Science Board to the Food and Drug Administration Advisory Committee; Notice of MeetingThe Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration (Science Board). The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its […]