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Commercial Ship Marine Engineering Surveyor Consultant. MEngTech DipMarSur MEng NavArch
Expert and his team are the leading providers of independent Commercial Shipping and Vessel Marine Engineering, Marine Surveying, and Inspection/Examination services to the Maritime Industry, for Global Marine Insurance (Loyds/Xchanging/DNV) Underwriters and Maritime Safety Agencies. Our expertise features strongly in…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Analysis of Polymer Additives, NMR & other Techniques
Current interests include studies on the oxidation and stabilisation of polyolefins, the antioxidant mechanisms and performance of biological antioxidant in polymers, synthesis of reactive compatibilisers for polymer blends, upgrading properties of polymers by reactive processing techniques, free radical grafting reactions…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Real-Time Embedded Control Software
Experience and expertise is in real-time embedded software and its development, IP, training and support. Having experience working with small to mid-sized companies in communications, automation, consumer electronics and automotive industries, Expert has participated in many facets of business, obtaining…
Rheology, Nanotechnology, Particulate/Multiphase Processes, Chemical Engineering.
Expert operates his contract research & development small business incorporated in 1990 in Saint Paul, Minnesota, USA. Expert's professional experience spanning over four decades in chemical engineering has focused around the broad areas of particulate/multiphase processes and rheology. Chemical engineering…
Valves, Control Valves, Piping, Pipe Couplings, Pipe Joining, Valve Testing, Valve Codes, and Standards
Expert, PE is an engineering consultant with over 35 years of mechanical engineering experience. Licensed Professional Engineer in NY and PA. Services provided include consulting and expert witness in the following areas: Product Safety Signs and Labels, Guards and Barriers,…
Chemical and Pharmaceutical Development – Comprehensive CMC
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…
Designing and Implementing Quality Control Stability Programs, Authoring Stability Sections
Expert has over 10 years experience in the areas of QC Stability (Drug Product and API). In addition, Expert has many years of experience in drafting QC Stability sections for the following submissions for the FDA: IND, NDA, BLA, PAS,…
Rapid Development of Controlled Release Drug and Drug-Device Combination Products
Expert, Ph.D., is an independent consultant with 15+ years experience in developing controlled release implantable and injectable products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, with special focus on drug delivery platforms and drug-device…