MARCH - MAY - 20237 HCI is a niche cell therapy, gene therapy, gene editing, combination product, tissue engineering, regenerative medicine, and xenotransplantation consulting and advisory firm. Served over 125 clients in these fields with 20 deep subject matter experts for FDA regulatory strategy/submissions/ meetings/operations/publishing, CMC/manufacturing/process/testing, QA/QC/GTP/GMP, translational and clinical R&D and Operations, and diligence/licensing/NewCo support. Specific Discipline Expertise Global regulatory affairs strategy and content FDA CBER and CVM), including CMC, pharmacology/toxicology, clinical and general regulatory (e.g., expedited) disciplines CMC Process Development and Analytical Development QA, QC, GxP Translational R&D Clinical Technical/product/platform/regulatory diligence activities Regulatory publishing/eCTD support. Unique education/expertise across academia, industry, government/FDA and consulting experience in: Cell Therapy Ex Vivo (cell-based)/In Vivo Gene Therapy Gene Editing Technologies and gene editing products (Ex Vivo/In Vivo) Exosomes 361 HCT/Ps Related Medical devices Related Combination Products Related Ancillary Materials, Biological Starting Materials, and more. About Chief Consultant & Other Key Experts Please see: https://www.ourhybridconcepts.com/chief-consultant-advisor https://www.ourhybridconcepts.com/key-consultants Michael Mendicino, Ph.D.Owner, Chief Consultant & Advisor Cell: +1 (434) 294-9056 Fax: +1 (434) 264-7073 www.ourhybridconcepts.com LinkedIn: https://www.linkedin.com/in/michaelmendicinophd/ SM SM
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