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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…
Digital Transformation: Risk and Engineering
Working with global and international clients and organizations to address emerging, evolving and rapidly changing enterprise risk, governance, risk and compliance, operational risk and resilience, business continuity, crisis management, organizational and digital transformation, as well as control system testing, review,…
Biocompatibility Testing and Biomaterials for Medical Devices
Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…
Formulation Chemistry
Spray drying expertise in volatile solvents and end-user food powder products. A lead formulation chemist with over eight years of experience in the area of the formulation. A talented chemist that excels in a high-performing multidisciplinary research environment in the…
Avionics, Audio Software, Hardware Development
Avionics DO-178C certification documentation, embedded software development C, Audio DSP coding, .NET C++, C#, desktop app coding, Analog/ Digital Electronic circuit design. Software and Electrical Engineer with 25+ years’ experience in design, development, and verification of embedded system software and…
Electronics Assembly and Manufacturing
Expert's expertise is in electronics assembly and manufacture. Summary: - Seasoned "Get it Done" (Electronic) Design/Process/Manufacturing Engineer with a proven track record of making a significant impact. Able to flourish in a fast-paced global organization that runs 24/7. Averted customer…
Electrical Engineering, Including: Power Systems Analysis, Arc-Flash Hazard Studies, Short Circuit Studies & Building Electrical Design
Expert is a licensed professional electrical engineer in Decatur, Alabama, with over 35 years of extensive experience in electrical and electronics engineering. He has a broad range of skills including short-circuit and protective device coordination studies, arc-flash hazard analysis, Allen…
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…
Sourcing / Procurement / SCM Functions
Expert is a seasoned Procurement / SCM professional with over 30 years of industry experience with a reputed diversified group of companies. He has been heading Procurement / Sourcing / SCM functions in a complex business environment for 23 years…
Biomaterials, Biotechnology, Medical Devices, Polymer Chemistry, Biomedical Engineering, Materials Engineering, Healthcare (regulatory), Intellectual Property Strategy
Expert has more than 20 years experience in biomaterials and medical devices, both in industry and as a university professor performing research. His research has a translational focus, so he has conducted numerous pivotal animal studies related to the fields…