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Drug Delivery Modeling
Expert is an independent modeling consultant from Huntsville, Alabama. Until recently, he was a senior principal scientist in CFD Research Corporation (CFDRC), Huntsville, Alabama. He has a strong background in PBBM/PBPK modeling and simulation methods, CFD, scientific computing, mathematical modeling…
Pediatric Nursing (with Doctorate)
Board Certified and Doctoraly prepared Pediatric Nurse Practitioner with over 20 years caring for children. Published author on various pediatric topics in peer reviewed journals. Podium presentations at the national and state level on various topics of pediatrics. Coordinator of…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Strategic Marketing and Business Management in all Healthcare and Medical Sectors
• Successful, enthusiastic, highly motivated, strategic medical/healthcare consultant • Qualified, experienced international business manager & strategic medical marketer • Excellent track record of turning round and growing companies, products & services • Wide span of management expertise across pharmaceutical, medical…
Pulmonary and Critical Care Clinical Medicine
Expert is a busy clinical pulmonary physician who treats many patients with pulmonary diseases. He has been board certified by the American Board of Internal Medicine in Pulmonary Diseases for nearly 20 years. He reads pulmonary function tests regularly, and…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert…