Organic Chemist in Pharmaceutical Development and Quality Compliance, with Biopharmaceutical and Medical Device DevelopmentPharmaceutical development and quality compliance.Biopharmaceutical and medical device development.Development of pharmaceutical activates related to controlled release drug elute stent medical devices.Contract Service Provider (CRO) management.API development, vendor selection and CMC submission.Bioanalytical method development, validation and testing.Regulatory requirements and compliance, identify pathway, development strategy, define scope and preform gap analysis.Regulatory submissions and preparations (IND, amen...

Analytical Chemistry Consultant Specializing in Drug Stability and cGMP, FDA, and ICH Quality and ComplianceManage pharmaceutical commercial internal-external stability programs providing, guidance for laboratory investigations, input for laboratory information management systems, support sample management programs, and support data review. Provide support to Operational Excellence Projects.Ensuring stability studies are conducted to support regulatory commitments.Communicating trending stability data from the QC laboratory and contract laboratories.Drug stability program management for development and commercial products.Statistical anal...

Drug-Development Expert (Pre-IND to Marketed Products), Pharmaceutical Development Strategy, Regulatory (Domestic and European)Full spectrum of drug development; (pre-IND to marketed products) and development of multiple pharmaceutical products.Global regulatory challenges in drug development and handling a wide range of drug development.Regulatory strategy and CMC strategy.Gap analysis and review of the CMC package.IND and pre-IND submissions.Pre-IN, IND, (Investigation New Drug), CTA, (Clinical Trial Approvals), IMPD, (Investigational Medicinal Product Dossier), NDA (New Drug Application) and MAA (Marketing Authorization Applications) s...

Ph.D. with expertise in Drug Metabolism and Pharmacokinetics, Pharmacodynamics, and Toxicokinetics. Investigational New Drug approval experience in USA and ChinaDMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes...

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...

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...

Pharma DMFs Compilation, Review and Filing in Various Regulatory Authorities and Marketing Procedures (CP/DCP/MRP/NA) i.e., Europe, EDQM, USFDA, TPD-Canada and TGA-Australia with Accordance to Filing Drug Master File (DMF)/ Active substance Master File (ASMF) for the domestic and global industries. USDMF: United States Drug Master File, (Open and closed part). Certificate of Suitability (CEP-COS) of EDQM. eCTD Compilation. DMF-Life cycle management. Technical Packages for Pharma Intermediates. DMF review as per ICH guidance. Analytical Method Validation and Development for API (Active Pharmaceutical Ingredients) and Pharma Interme...

Medical Device and Pharmaceuticals Quality Management Expert Witness with Experience in Clinical Research, Regulatory Affairs, and ISO-9000 ComplianceQuality assurance, clinical research and regulatory affairs to assist in quality systems improvements, product development, and marketing approval of medical products.Quality management for medical devices, pharmaceuticals, and biologicals.GLP, cGMP, GCP, ISO-13485 and ISO-9000 regulations as they apply to quality systems audits to assure compliance with regulations and standards.Expert Witness ExperienceFive cases, one court testimony.Assisted in the reversal of three Federal Court consent...