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Expert ID: 723693 Florida, USA

Expert in 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…

Expert ID: 733385 Minnesota, USA

Expert in Pharmaceuticals: Formulations, Injectables, Topicals, Analgesics, Pharmaceutical Analysis

CORE SKILLS Instrumentation skills. APIs/preformulation: X-ray diffraction; Raman spectroscopy; HPLC (potency, degradants, purity, linearity, accuracy, precision, LOQ, LOD) with detection via UV-Vis, fluorescence, and conductivity; content uniformity, dissolution/elution incl. sustained- and immediate release formulations, paddle wheel apparatus; forced degradation incl.…

Expert ID: 730909 Texas, USA

Expert in Commissioning, Start-up and Validation of Biotechnology and Pharmaceutical Processes

Expert has over 30 years' experience in research, development, QA/QC, technical service, validation, manufacturing and engineering management. All of the above have taken place in the food, pharmaceutical and biotechnology industries. Expert has formal training in microbial physiology, biochemistry and…

Expert ID: 729835 New Jersey, USA

Expert in 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…

Expert ID: 729777 Oklahoma, USA

Expert in Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China

Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up a cGMP manufacturing…

Expert ID: 729380 New Jersey, USA

Expert in Pharmaceutical/Biotech Marketing | Brand Marketing | P&L Management | Commercial Strategy

Expert. Expert is a strategic advisor to the life sciences industry drawing on more then 25 years of sales, marketing and managed markets experience in commercial healthcare organizations. He has worked both as client and vendor (pharma/biotech executive and ad…

Expert ID: 726936 Ohio, USA

Expert in 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…

Expert ID: 726302 India

Expert in 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…

Expert ID: 726016 New Jersey, USA

Expert in 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…

Expert ID: 724696 New Jersey, USA

Expert in Pharmaceutical Marketing and Litigation, Major Pharmaceutical Trends, International Business

Expert has been a Vice President, Marketing for two major pharmaceutical companies, most recently Pfizer, overseeing sales of $600 million. He has twenty years of experience in pharmaceutical marketing Expert was a Managing Director for the Nordic region in Europe…

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