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Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Intellectual Property, Licensing, Various Technologies & Tech Standards
Expert is the Chief Intellectual Property Officer of a large healthcare conglomerate based in Los Angeles, CA.; Comprised of numerous companies which proudly hold foundational intellectual property in a number of disciplines including by not limited to blood based biopsies,…
Corrosion, Materials Selection, Fabrication
Expert has worked in the area of sulfuric acid plant corrosion and materials selection for the past 18 years and has been involved in the materials selection of some of the worlds largest sulfuric acid plants. Expert has performed failure…
Biological Systems Engineering
- Biological systems engineer, marine biologist, ecologist, environmental scientist, and biotechnologist with commercial operations and research experience leading, designing, developing, executing, and managing projects. - Innovative applied scientist and engineer with a multitude of skills, a patent portfolio, over 20…
New business development & new product applications for domestic & International businesses
Expert is founder and president of an international marketing group. Prior to forming his company, he was a principal of a LLC, Vice President, Sales and Marketing as well as many other executive roles in his career. He has over…
Pharmaceutical Processing and Packaging
Expert has over 20 years of experience in engineering and technical services. He has lead teams of engineers working in development, material qualification process development/ qualification, as well as lifecycle management for both new and existing combination/ non-combination products. Expert…
Business Optimization, Engineering, Analytical Rigor, Technical Expertise, Due Diligence, Critical Business Analysis to Develop/Implement Change for Profitable Growth
We fuse business optimization, engineering expertise, analytical rigor, and technical expertise to help companies perform due diligence, critical business analysis and design/implement continuous improvement programs to achieve profitable growth. Our firm provides expertise in commercial development, new product development, sourcing,…
Chemical engineering research & development – specifically separation processes including carbon capture via solvent absorption, solvent extraction, pilot plants, literature reviews.
The expert has extensive experience in the research and development of separations technologies and their application within the industry. She has conducted both fundamental and applied research within the fields of gas absorption for CO2 capture and solvent extraction for…
Coatings; Powder, liquid, Electrocoating and metal finishing process
As a Continue Improvement Manager (holding a Managerial position company deems fit), Expert is offering his engineering education, managerial experience, training in Lean manufacturing principles and Kaizen facilitation expertise to Operations, Business Unit or Production Area at a Manufacturing, Pharmaceutical,…