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Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Pharmaceutical Sciences (Small Molecules and Peptide Delivery), Novel Drug Delivery (Micelles, Liposomes, and Insitu Forming Gel), and Conventional Dosage Forms (Solid, Semisolid, and Liquid)
Expert is an experienced pharmacist with a demonstrated history of working in the pharmaceuticals industry. A skilled researcher, she is knowledgeable of R&D development in Pharmaceutics (small molecules), cosmetics and OTC (herbal products). Expert is experienced in industry and academic…
Cosmetic Dermatology products & services, including Neuromodulators/Dermal Fillers/Lasers/Peels
Expert began injecting Botox Cosmetic® when it was FDA-approved for strabismus, but not yet for wrinkles. Then a resident at the University of Miami Miller School of Medicine's Department of Dermatology & Cutaneous Surgery, she was among the first physicians…
Pharmaceuticals & Healthcare in Brazil: Entry Strategy, Market Evaluation & BD
Expert has ran 6 pharma & healthcare businesses as General Manager/CEO/President in his 40 years in Brazil ranging from subsidiaries of US, German, UK & Latin American labs to local start ups. Businesses covered Rx & hospital products, OTCs &…
Beauty, Color Cosmetics, Make-up Art, Education, Product Development, Fashion, and Concept, Personal Protective Equipment, PPE, Negotiations, Middle Agent
Expert brings years of Beauty, Color Cosmetics, and Image development experience from the consumer products industry to fashion and entertainment. She has helped launched powerful brands utilizing her ability to come up with innovative products to market and led comprehensive…
Cosmetics, Packaged OTC Drugs, Nutraceuticals, Design, Processing, Quality Issues
Expert has fifty years of actual bench experience doing laboratory and pilot development of the listed areas of expertise. Expert has visited the FDA over 100 times in support of various submissions. Expert has worked for several contract manufactures of…
Personal Care and OTC Products; New and Existing Product Formulation and Development
Expert has been involved in formulating a variety of cosmetics, personal care and OTC products. She works with formulation and manufacturing development of skin care, anti-wrinkle (Elastiderm Decolletage Wrinkle Reducing Lotion), eye area (Elastiderm Eye Treatment Cream), anti-rosacea (Hydrating Complexion…
Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer’s and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic’s regulations. Moreover, her firm has extensive experience in…
Aesthetic and Cosmetic Medicine
After finishing his undergraduate in 1992, Prof. Expert obtained three separate diplomas including in Child Health (DCH), in Dermatological Science (DDSc) and in Genito-Urinary Medicine (Dip GUM) in 1996. He received his PhD from the University of Wales College of…
Otolaryngology, Head and Neck Surgery, Plastic and Reconstructive Surgery
Expert, M.D., F.A.C.S., is board certified in otolaryngology as well as facial plastic and reconstructive surgery. He is also board certified and fellowship-trained facial plastic and reconstructive surgeon. He received his MD from Rush Medical College in 1998 and completed…