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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…
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…
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…
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,…
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…
Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. She has worked…
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,…
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.…
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,…
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…