Pharmaceutical Development Expert: Planning, Portfolio, Technical Analysis and LicensingPharmaceutical and biotechnology business development and new product planning.In and Out licensing and strategic partnering.Commercial analysis and forecasting.Pharmaceutical life cycle management.Start-up of Pharmaceuticals, business building in proprietary, generic, and OTC pharmaceuticals and biotechnology, providing modeling and commercial assessments.Undisclosed Company, Chief Consultant, 2014 - PresentPrepared for pharmaceutical start-up forecast models and...

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...

Ph.D. Cellular & Molecular Medicine Consultant with Expertise in Pharmaceutical Development, DNA and RNA Sequencing, Translational Research and Clinical Trial Development SpecialistPreclinical pharmaceutical development and therapeutic analysis in rodents.Investor due diligence of preclinical data.Cancer genetics, genomics, epigenetics, and epigenomes.Bioinformatics.Genetically engineered and transplantable animal models of disease.High throughput and next generation DNA and RNA sequencing.Genome engineering using CRISPR.Molecular biology and pharmacology.Biomarker development and testing.

Analytical chemist expert in development, validation and transfer of methods for pharmaceutical regulatory filings such as IND, ND, NDA, eCTDSeparation science HPLC, ion chromatography, chiral HPLC, GCAnalytical method development and validation analytical method technical transferLaboratory equipment and instrument qualification and calibrationDesign and setup of GMO and GLP Analytical LaboratoriesRaw material and drug substance characterizationPhysical chemical characterization and structure elucidationProject management for bioanalytical and analytical laboratoriesBioanalytical method developmentQuality assurance for GMO and GMOP labora...

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...

Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...

Large Molecule Bioanalytical Consultant with PK, PD, and ADA experience. Over 20 Years Experience Developing and Validating Bioanalytical Methods to Support Drug Development Programs.  Experience in Summary  Accomplished bioanalytical scientist with extensive and diverse experiences in biotechnology and pharmaceutical industries.  Strong reputation for planning and organizing, analytical problem solving, multi-tasking. and coordinating team efforts.  Creative, collaboration and highly goal-driven scientist.  Expert in Ligand Binding Assays including immunogenicity. Successfully implemented complex acid...

Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...

Consultant in Computational Modeling. Drug Design, Proteins, Small Molecules, Genetics, Machine Learning, Artificial Intelligence, Bioinformatics and Biomedicine, Materials Discovery, Robotics & ContrSummary  Drug discovery consulting and research and development in Biomedicine. Providing over ten years in biomolecular computational methods (small molecules and proteins, proteomics, genetics).   Drug Discovery and Biomedicine - Health  High throughput virtual screening and docking. Drug candidate identification. QSAR (Quantitative Structure Activity Relationship) and QSPR (Quantitative Structure Property...

Interpretation and Analysis of Technical Intellectual Property Related Documents in English and Japanese. Biochemistry and Cellular Biology Background in Biologics and Small Molecule Drug Discovery and Development. Drug Substance In Vitro Assay Development and StandardizationInterpretation and analysis of highly technical Japanese documents in English.Pharmaceutical and biotechnology research project management.Biochemistry - cellular biology background: Biologics and small molecule drug discovery and development.Liaison and interpreter for licensing and material transfers to and from Japanese organization.Manager of in vitro pharmacol...