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Expert ID: 727750 Canada

Expert in 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…

Expert ID: 727557 Colorado, USA

Expert in Licensing, Biopharma, Pharma, Medical Devices, Chemistry, Agreements, Business Development

Expert has more than 25 years of expertise in transactional and regulatory counseling, acquisition, licensing, due diligence, dispute resolution, opinions, and appeals for the development and commercialization of health care, pharmaceutical, biotechnology, chemical, computer and electronics technologies. With more than…

Expert ID: 726978 Illinois, USA

Expert 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…

Expert ID: 726302 Australia

Expert in Formulation, Development and Manufacturing of Pharmaceutical Dosage Forms

Expert has extensive product development experience in solid dosage forms (TABLETS {IR & ER} HARD & SOFT GELATIN CAPSULES AND POWDERS); Liquid dosage forms ( SOLUTIONS, SUSPENSIONS & EMULSIONS) from conception through to stability trail, clinical studies, validation; final manufacture,…

Expert ID: 726049 Puerto Rico

Expert in Validation

Expert has been an independent Validation Consultant for around 10 years; he is responsable for the management of validation projects. He supervises resources acting as a project manager and is also responsible for the development and execution of validation protocols,…

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: 725858 India

Expert in 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,…

Expert ID: 725712 Pennsylvania, USA

Expert in Pharmaceutical Process Research, Development, and Manufacturing

Expert has 17 years experience of research, development and manufacturing of APIs. Expert has three patents from research, development and manufacturing of etoposide and etoposide phosphate. He also has extensive experience with platinum anticancer drugs, including cisplatin, carboplatin, and oxaliplatin.…

Expert ID: 725448 Colorado, USA

Expert in Pharmaceutical Facilities, Pharmaceutical Manufacturing Processes, Facility FDA Compliance

In addition to having primary responsibility for numerous pharmaceutical construction projects over the last 15 years, Expert has also held several positions with pharmaceutical and medical device companies where he was responsible for the daily operations of facilities engineering, maintenance,…

Expert ID: 725402 Ohio, USA

Expert in Specialty and Fine Chemicals, Pharmaceuticals, Resins, Coatings

He has worked in the process development, manufacturing related to the technologies, chemistries. He has also worked in intellectual property strategy, commercialization of many different technologies. He is able to do this as he has cross- fertilized manufacturing and processes…

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