Intellectual Property and Regulatory Consultant Specializing in Patents on and FDA Regulation of Novel Medical Device and Biotech DevicesIntellectual property (IP) and regulatory strategy.FDA regulation of novel products such as wearable medical devices, and electronic cigarettes.Patent protection of drugs, medical devices, dietary supplements, and tobacco products.Patent landscaping and freedom-to-operate analyses.Consultation with and representation before U.S. Food and Drug Administration (FDA).IP and regulation surrounding novel technologies such as RNAi, gene editing, and synthetic biology.In vitro diagnostic medical device and consu...

Ph.D. Cosmetic and Personal Care Consultant with Expertise in Bio-Active Complexes for Formulation, Claim Substantiation, Active Ingredients, INCI Regulations, Skin Care, and Hair CareIdentifying and developing innovative biologically active raw materials leading to the formulation of successful skin care and topical dermatological OTC products.Development of formulations by designing the bio-active ingredient combinations.Help oversee In vitro and In vivo activity testing.Develop product claims and claim substantiation.Work with marketing and public relations to communicate technology to the press and consumers.Knowledge of labeling regu...

Dental and Technology Industry Consultant: Dental Devices, Laser, Intellectual Property, Medical Malpractice, Patent Infringements, Prior Art, and FDA WorkMedical laser technology and product development with specific focus to the Medical Infectious Disease and Dental Surgical industry.Bacterial and fungal elimination laser system.Photobiology technology in the medical and dental industry.FDA Approvals (FDA 510(k). Products: Lumenis, Contact Bone Ablation with Er:YAG lasers and OPUSDUO; OPUSDUO E; OPUSDUO EC, OPUS 20; and OPUS SPECTRUM.FDA cleared and CE Mark approved Onychomycosis Laser System selling world-wide.Dual Wavelength Infrared...

Ph.D. Oncologist with Expertise in Cloning Studies and Flow Cytomertry Panel Design and Immuno-Oncology Study Design in Humanized MiceImmuno-oncologist in various immunological and flowcytometric assays designs for humans and mice.Flowcytometry: Designing and running panels (both intracellular and surface) using various machines on 4-10 color platforms (BD FACS Aria, Calibur, LSR II, Canto, MoFlo) on human PBMCs, AML samples from patients and mouse cells ex vivo and in preclinical humanized models of mice on NOG platform.Creating and studying in vivo mouse models to analyze T and myeloid cells from humans and mice (RAG/BALB/C57Bl6) for in...

Designing, Commissioning, Qualification and Validation in the Pharmaceutical IndustryPharmaceutical standards regulations: BPF, BPL, GMP, Europ%uFFFFe Pharmacop%uFFFF and FDA 21CFR part.11.Quality assurance and the standards regulations requirements for the pharmaceutical industry.MethodologyRisk Analysis (AMDEC, HACCP)Six SigmaTechnical ExecutionPharmaceutical quality assurance and the standards regulations requirements.Design, quality, commissioning and qualification documentation of pharmaceutical processes.FAT, (Factory Acceptance Testing),SAT, (Site Acceptance Testing) commissioning, (re)qualification and validation tests.Aseptic pro...

Estuarine and Marine Ecosystems Assessments, Studies, Determining Aquatic Ecosystems and Marine And Atmospheric ConsultingExtensive wet lab, dry lab, and field work experience including:  Environmental ecosystem assessments in the computing languages R and Matlab. Application of multivariate, univariate, and spatial statistics to environmental datasets. Image analyses in ImageJ. Application of high-performance liquid chromatography (HPLC) and microscopic approaches for environmental samples. Analysis and interpretation of next-generation sequencing data and molecular samples for microbial community assessments. Culturing and i...

Biologics Pharmaceutical Development and Manufacturing Consultant for Clinical and Commercial Products. Formulation Development Work and Stability Testing, from Early Stage Through Commercial, for Proteins, Monoclonal Antibodies, Vaccines and Small Molecules.Biologics pharmaceutical development and manufacturing, working in process development, purification, formulation, lyophilization, analytical development and stability for both clinical and commercial products.Formulation development work and stability testing, from early stage through commercial, for proteins, monoclonal antibodies, vaccines and small molecules.Sterile fill support f...

Strategic Chemical and Specialty Chemicals Technology Management: New Drug Applications and DevelopmentGuiding clients through complex chemical technology development programs.Identifying new technology enabling business opportunities, process improvements, debottlenecking opportunities, and planning capital upgrades to increase productivity of specialty chemical plants.Defining the content of the(CMC) Chemistry Manufacturing Controls component of new drug applications (NDA) and developing the strategy for completion of necessary work in individual technology areas.Leading the effort to develop a guiding vision and organizational structur...

Pharmaceutical Microbiology Quality and Regulatory Consultant with Expertise in Process Validation, Steam Sterilization, PDA's, ASQ Certified.Regulatory affairs and quality assurance certified with ASQ.Over Twenty-five year's expertise in sterile process validation, steam sterilization and aseptic processing.Pharmaceutical microbiology, and chaired PDA's Microbiology and Environmental Monitoring Interest Group for over fifteen years.GMPs, data integrity, sterile process validation, steam sterilization, microbiology, environmental monitoring, regulatory updates, and conducting regulatory submissions.Expert Witness ExperienceInternational pa...

Experienced Senior Scientist Obtains Proven Track Record in Research and Product Development, Support, Validation. Clinical Assay Development, Medical Devices, Planning- Executing 510(k) Applications.Summary Experienced Senior Scientist with a proven track record in research and product development/ support/ validation. Clinical Chemistry Expert; polymer chemistry, assay development, medical devices, fluorescence, planning and executing 510(k) studies, writing and editing 510(k) applications. Subject matter expert for chemistry and test method validation on behalf of clients’ companies. Numerous processes validation during compli...