Find an Expert
Medical Device Development
BSME - Mechanical Engineer: 40+ years Medical Device design & development (13 patents) - Drug delivery devices, respiratory care devices, hemodialysis, and blood collection devices, in-vitro diagnostic instrument, and cartridge devices; 25+ years medical device product liability and patent infringement…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Ultrasound
Seasoned medical device Research and Development professional practiced in leading cross-functional engineering teams, developing and executing technology roadmaps, and driving strategic expansion of intellectual property (IP) portfolios. Over 15 years of experience in product development, including ultrasound imaging systems, ultrasound…
Physical Therapy
1969 B.S. SUNY Downstate College of Health Related Professions, 1971 M.S. Exercise Physiology Long Island University, Masters Degree Thesis: A Comparison of the Effectiveness of Eccentric Vs. Concentric Strength Training Programs on the Contractile Strength of the Elbow Flexors. 1995…
Neurosurgery/ Complex Spine Surgery
Expert is an academic neurosurgeon specialized in complex spine/deformity surgery, currently practicing as Assistant Professor at the Division of Neurosurgery at very prestigious university. During the past years, he has had the privilege of teaching and mentoring several residents in…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Formulation
Pharmaceutical product development, scale-up, commercial manufacturing. Process design, improvements, economic changes. Complex product development, bioavailability, absorption enhancement. Intellectual property analysis and guidelines for alternative strategies. Sourcing, quality, regulatory CMC guidance. Proven track record of 30 years in effective product development…
Biomedical Informatics, Biomedical Engineering
Clinical Informatics, Electronic Health Records, Clinical Decision Support, Health Information technology, audit logs
Vaccine Development
More than 30 years vaccine development at GSK Biologicals managing process development, GMP clinical lots manufacturing, validations activities, regulatory submissions, Quality matters,..... Overall, development of more than 50 projects (bacterial, viral, recombinant yeast, CHO, viruses, E.coli and adjuvant systems)with signifiant…