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Drug marketing, Drug intellectual property & patent, Drug benefits, Specialty pharmacy, Pharmacy benefit management, Evidence-based drug Use
Since 1989, Expert has provided consulting related to pharmacy benefits, marketing of pharmaceuticals, biotechnology and biological products, pharmaceuticals-related business strategy and new business development. Consulting engagements typically involve situation/opportunity assessment, proforma market and price modeling, business strategy and development, market…
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…
Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services
Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. Played critical roles in several…
Pharmaceutical and Biopharmaceutical Product Development, Formulation and Stabilization Technology
Expert has fifteen years of experience in product development, formulation development, and drug delivery for pharmaceutical and diagnostic industries. She has thoroughly developed skills in research planning, product formulation, and analytical problem solving. Expert has expertise in the fields of…
Diabetes, In-patient Diabetes Management, Thyroid and Pituitary Diseases
Expert has been practicing endocrinologist for nearly 23 years. His expertise is in managing out and in-patient diabetics, identifying their complications, managing their insulin or other diabetes drugs oral or injectable. He is especially interested in managing hospiatalized, pre and…
Product Development, Quality Assurance, GMP Audits, Qualifications, Troubleshooting, Pharmaceutical, Nutraceutical, Production Issues, GMP Compliance, Pharmaceutical Dosage Forms, Quality Control
Expert has more than 24 years of experience Internationally (New Zealand; Australia; Oman, and India) in pharmaceutical formulation plants, Product Development; Analytical development; Scale-up, Technology transfer; Manufacturing, Quality Assurance; quality control (testing and releasing); Lead regulatory audits and meet the…
Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition…
Critical Care Nursing, Nursing Student Liability, Critical Care Technology
After 30 years of clinical practice, as well as her recent teaching experience, she feels confident to describe herself as a "expert" in critical care nursing. Although there is always so much to learn, she feels she makes a most…
Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, projects,…
Spain Drug Market, Drug Reimbursement, Drug Therapy, Generic Drug Market, Biologic Therapy, HIV, Oncology, Hematology
Expert is an hospital pharmacy specialist, with a PhD and Masters in Pharmaceutical Care and Pharmacy Oncology Diplomade from Valencia University, Spain, as well as a Masters in Pharmacovigilance from Sevilla University, Spain. Expert is a clinical pharmacist of the…