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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…
GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…
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…
Family Practice Medicine, Geriatric Medicine, Addiction Treatment
Expert has been in the private practice of medicine for over 30 years. During this time, he has served as Chief of the Department of Family Practice, Chief Quality Officer, and Chief of the Medical Staff at Frederick Memorial Hospital,…
Assisted Reproductive Technology, Infertility Care, Endometriosis, Polycystic Ovarian Syndrome
Expert's expertise lies in advanced reproductive care. Clinical areas having an impact on fertility include management of endometriosis, ovulatory dysfunction, recuurent pregnancy loss, abnormal development of female anatomy. Technical areas of expertise include ultrasonography, minimal access surgery including laparoscopy and…
Obstetrics and Gynecology
Expert is a board certified gynecologist. After receiving his M.D. from Albert Einstein College of Medicine in 1988, he completed his internship and resident training in gynecology at Geisinger Medical Center in 1992. He is board certified by the American…
Behavioral Science, Memory, Psychopharmacology, Statistics, Research Design, Sensation & Perception
He has conducted several research studies on nicotine and nicotine withdrawal, as well as the mnemonic effects of benzodiazepines. He has conducted studies examining the anesthetic drug midazolam and it's effects on human memory. He has extensive training and experience…
Nursing, Medical Literature, Healthcare
Expert started her career as a medical/surgical and hematology/oncology nurse working at Children's Hospital. She received her master's degree in (clinical nurse specialist and nurse practitioner) pediatrics from the University of Delaware. Expert went on to take a position at…
Medicine, Pharmacy, Pharmacology/Toxicology with Emphasis on Cannabanoids and Opioids
Expert is a practicing physician and pharmacist, who also holds a Master's of Science degree in Pharmacology and Toxicology. He has performed research in the field of Pharmacology with particular focus on drugs of abuse, cannabinoids and opioids. He has…
Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. Expert has 15 years of experience in the design,…