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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…
Biocompatibility Testing and Biomaterials for Medical Devices
Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…
Medicinal Chemistry/ Synthetic Organic Chemistry-Research and Patent Litigation
Experienced Medicinal Chemist and Consultant: expert at synthetic organic chemistry, pharmaceutical chemistry, pharmaceutical patent litigation, patent analysis: 1) Eight years of consulting experience, beginning in Jan. 2012, writing expert reports following patent analysis covering obviousness, claims validation, enablement; depositions given.…
Medical Dermatology, Allergy, Immunology and Biochemistry
Expert is a practicing physician-scientist and an academician with a robust, proven track record of managing the most complicated cases in medical dermatology requiring treatment of patients with a variety of topical and systemic medications (including, without limitation, corticosteroids, immunosuppressors,…
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…
Phlebotomy-Related Injuries
Expert has over 25 years of experience in phlebotomy, including overseeing the phlebotomy departments at Memorial Sloan Kettering Cancer Center and St. Vincent’s Comprehensive Cancer Center in New York, NY. In these roles, he was responsible for training, supervising, counseling,…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Medical Oncology, Cancer Biology, Signal Transduction
Expert is board certified in Internal Medicine and Medical Oncology and has a clinical focus on gastrointestinal malignancy, specifically colorectal and pancreatic cancer. Expert studies signal transduction pathways relevant to human cancers in an effort to target these pathways for…
Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…
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…