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Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…
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…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…
Medical Device Software, Safety Critical Systems, Embedded Systems Design
Expert managed the Electrical Engineering department of a consulting company specializing in medical device design. He has designed software, firmware and hardware for medical devices including a Proton Beam Radiotherapy system, blood infusion pumps, blood analyzers, hysterscopic pump, drug scanning…
Pharmaceutical Chemical Process R&D, Manufacturing, Disaster Recovery, Software Design
As the IT Manager for a major pharmaceutical company Expert has expertise in selection and validation of document management systems, inventory control, instrument calibration systems, as well as computer software utilized in the pharmaceutical industry as a whole. He has…
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,…
Accident Reconstruction, Biomechanical, Mechanical, and Neuroelectrical Medical Device Engineering.
Expert understands brain, spinal and orthopedic biomechanics and has analyzed hundreds of cases to determine the causation of injuries sustained by drivers, workers and citizens. He has performed biomechanical research using cadaveric models to understand the kinematic behavior of joints,…
E-beam Imaging Product and Material Development, Laser, FDA Radiation and Product Safety Compliance
Expert is a well-qualified professional with more than 15 years of experience in designing electronic products and materials for high kV electron beam and x-ray imaging applications . He has got extensive knowledge in image processing and analysis of the…
Life Sciences, Lab IT Support & Validation
Worked as a group leader as well as R & D Sr.. scientist. Expertise in analytical method development and testing. Worked with NDA and ANDA products with different clients. Directly communicating with clients regarding progress and any problems in development…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…