Pharmaceutical Quality Assurance Quality Control expert with experience with U.S., E.U., Canada, and India regulationsPharmaceutical Quality Assurance and Regulatory Affairs.Compliance audit, Quality Operations and Regulatory Submissions.Design and implementation of Quality Systems and regulatory compliance programs.Domestic and international quality and regulatory compliance.Managing contract / vendor supply chain quality programs.Developing and delivering GMP, GDP, DI procedure training programs.Leading the Quality efforts to successfully remediate recurring failures.Generation, maintenance and revision of SOP's, specifications, procedur...

PhD Biostatistician with expertise in Regulatory (FAD and EMA activity), Data - Safety Monitoring in the Pharmaceutical and Medical Device Industries. Scientific Advisory Participant.Biotechnology FDA and EMA submission in the pharmaceutical and medical device industries.Biostatical litigation specific to pharmaceutical and medical devices.Pre- and Nonclinical, Phases I - IV in biostatistics, data management, statistical programming, and etechnology across various therapeutic areas.Analysis of over 420 clinical studies, with over 30 in Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE).Build effective innovative an...

Pharmaceutical GMP Consultant with expertise in GMP, QMS, Documentation, Validations, Plant setup, Training and development, Quality control, Audits, environmental monitoring, for Solid orals, Liquid Sterile, solid orals, liquid orals, dermal products; various dosage forms. Managing strategic and operational performance of Quality Department providing: Development and implementation, Standardized quality system processes, Review of standards for quality control, Regulatory compliance, Quality control systems and procedures (GLP). Pharmaceutical industry (Formulations). Quality Management System (QMS); Complaints, recalls, deviati...

Chemical engineer for front end process design specializing in polymers, refinery operations, chemicals and biochemical products.Chemical engineering consulting for 38 years with extensive global experience in the process industries, primarily related to polymers, refinery operations, chemical and biochemical products.Supervising start up and commissioning of new chemical plants.Lead chemical engineer of many projects, with responsibility for all aspects of planning, process design and supervision of other engineers.Process engineer on a nuclear waste disposal project in the United Kingdom.Experienced in fast track front-end process engin...

Pharmaceutical Regulatory Consultant with Broad SNDA, GMP, API Development Experience.Development of commercial manufacturing, FDA and international registration and approval for atracurium besylate, trifluoridine, bupropion hydrochloride, zidovudine, exosurf, mivacurium chloride, doxacurium chloride, pseudoephedrine hydrochloride, acrivastine, valciclovir, tramadol hydrochloride, topiramate, levofloxacin, surfaxin, vinorelbine tartrate and lamotrigine.Major process SNDAs for ofloxacin and leucovorin calcium.Regulatory documentation and approvals (FDA request for NDAs for grandfathered products) for digoxin, melphalan, azathioprine, thiogu...

Consultant with Diverse Pharmaceutical Experience in Formulation Development, Manufacturing, Technology and Site Transfer, Process Design, Scale-Up, and ValidationPharmaceutical formulation development, manufacturing technology transfer, site transfer, process design optimization, and scale-up for domestic and international clients.Product development using QbD approach, process scale-up and optimization, process validation.Drive technology platforms such as solid and Liquid orals, aseptic filling, softgels, orally disintegrating granules, powders, MR products, X-ray contrast media, peptide injectable product, topicals, steroids and hormo...

Chromatographic and Spectroscopic PhD. Analytical Chemist Chemistry in areas; LC-MS,GC-MS,ICP-MS, FT-IR,ICP-OES,CE for Drugs, Cosmetics, Pharmaceuticals, and Food.Analysis of drugs, pharmaceuticals, and cosmetics.Advanced Instrumental Analysis (LCMS,MS/MS,GCMS,ICPMS).Modern sample preparation techniques (SPE,QUECHERS).Laboratory quality management.Project management.Streamlining laboratory operations.Focused AreasGas chromatograph, (ECD/FID/FPD, GC and Mass spectrometry), head space sampler; High Performance Liquid Chromatograph ( PDA/UV/FLD/ELSD/RI); U(H)PLC; LC-MS(ESI,APCI);Ion chromatograph; on-line sample cleanup and enrichments for:...

Veterinary Pharmacology and Pharmacokinetics, Bibliographic Assistance, Tissue Residues and Product RegistrationPharmacokinetics in domestic animals.Tissue residues of veterinary drugs.Milk residues of veterinary drugs.Pharmaco-toxicological monographs for veterinary drugs.Registration and development of veterinary pharmaceuticals.Expert-Pharmaceutical RegistrationTechnical support for the development and registration of more than 200 pharmaceutical products for veterinary use in Argentina and Latin America.Independent Consultant...

Pharmaceutical Quality Auditor and Compliance Consultant for Human Tissue, Pharmaceuticals, and Medical DevicesQuality SystemSupplier quality system audits, supplier qualification, SCAR management and non-conforming material control and disposition.Quality system design: Medical device per QSR (21CFR PART 820) and ISO13485 requirements; and pharmaceutical per 21CFR 210.Designing Quality systems per 21CFR part 1271 (tissue and cellular therapy).Writing and reviewing Standard Operating procedures, SOPs and Work Instructions.Perform quality system audits per 21CFR 820 cGMPs (medical device), 221 cGMPs (pharmaceuticals), 600 cGMPs (biomedical)...

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...