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...

Licensed Pharmacist Skilled with Patent Litigation and Pharmaceutical Product Development Projects, Including Regulatory IssuesExpert Witness for pharmaceutical patent litigation.Pharmaceutical reformulation and the physical-chemical characterization of new chemical entities (NCE) and APIs.X-Ray diffraction, polymorphism, solubilization, stabilization and kinetics of pharmaceutical materials.Author of regulatory (IND/NDA/CTD) CMC sections and support documents.Project planning and management for pharmaceutical development projects, including virtual contract research (CRO) companies.Pharmaceutical method development preformulation and pilo...

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...

Consultant in Drug Discovery and Development; Preclinical and Clinical Drug Metabolism and Pharmacokinetics, Toxicokinetics, and Clinical Pharmacology; Preparation and Submission of IND's/ERC's and NDA's/MAA's.Over 35 years of experience in the discovery and development of novel drugs in multiple therapeutic areas (anti-bacterial, anti-inflammatory, anti-viral, cardiovascular, central nervous system, oncology, ophthalmic, pulmonary, and renal).Strong managerial and leadership skills with scientific expertise in the areas of drug discovery and development, preclinical and clinical drug metabolism, pharmacokinetics, and clinical pharmacology...

Pharmaceutical Drug Development Expert: Scale-up, Technology Transfer, Process Optimization, Troubleshooting, Clinical Supplies, FDA and ICH Quality and ComplianceManaging pharmaceutical operations, process and analytical methods development.New pharmaceutical product formulation development, scale-up, process start-up, optimization and troubleshooting.FDA-recognized expert in formulation development and technology transfer.Pharmaceutical licensing, Regulatory Affairs (CMC), quality systems and staff management.

Worldwide Pharmaceutical Expert Providing: Coordination and Technology of Pharmaceutical Products and Formulation and Development of Solids and ParenteralsSummaryExpertise in global product development, technology transfer/validation and business development.Designed and implemented development and registration strategies in U.S. and International arenas.Significant experience with all pharmaceutical dosage forms including peptides and novel delivery systems.Expert WitnessTwenty years of experience as an expert witness for pharmaceutical and formulation matters.