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Regulatory, FDA, Expert Witness and Pharmaceutical Chemist - Technical Consultant #687

Pharmaceutical Chemist and Former FDA Manager GMC, FDA Compliance and Expert WitnessRegulatoryFood and Drug Administration compliance.Prepare submissions to the Food and Drug Administration.Quality audits and implementation of changes.Simulated FDA inspection - quality and readiness audits.Establish and review quality assurance procedures for GMP and GLP.Develop and write appropriate Standard Operating Procedures (SOPs).Assist firms with Consent Decrees, Warning Letters, and 483s.Chemistry, Manufacturing, and Controls (CMC) expert.TechnicalLaboratory procedures and documentation.Pharmaceutical package and labeling and product compatibility...

Pharmaceutical Consultant Specializing in Preformulation, Pilot Plant Laboratories, Regulatory Compliance, Pharmacokinetics, Diabetes Medicinal-Chemistry and Expert Witness for Pharmaceutical Patent Litigation - Technical Consultant #1394

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...

Pharmaceutical Drug Stability Expert: ICH Compliance, Photochemistry, Photostability, Environmental Chemistry - Technical Consultant #1438

Expert in pharmaceutical drug stability, specializing in photochemistry and ICH compliancePharmaceutical drug stability testing. In depth knowledge of ICH guidelines and requirements for compliance.Photostability of pharmaceutical drugs. Photoprotection and stabilization of pharmaceutical drugs and sunscreens. Chemical actinometry. Solar simulation. Spectroradiometry.Aqueous-phase photochemistry. Identification and quantification of free radical oxidants and singlet molecular oxygen using spectroscopic techniques.Instrumental methods for identification and quantification of ground and surface water contaminants associated with hydraulic fr...

Business and Pharmaceutical Consultant with Pricing and Market Strategy Expertise - Technical Consultant #1497

National Pharmaceutical Science Specialist: Drug Pricing, Validation, Stability, Identification, Pharmaceutical Chemistry, and NDA filing, (GLP/GMP/cGMP)Pharmaceutical pricing.Pharmaceutical business development and sales.Pharmaceutical business strategy and decision making: Economic data analysis, tree analysis, probability of success calculations, resource and capacity requirements, drug pricing strategies, scenario presentations and critical path analysis.Pharmaceutical chemistry.Analytical method development and validation for drug stability, impurities, assay, release, content, uniformity, cleaning validation and identification.

Expert in Drug Stability, Drug Chemistry, Drug Development Test Method Development and cGMP, FDA, and ICH Quality - Technical Consultant #1522

Expert in Drug Stability, Drug Chemistry, Drug Development Test Method Development, Data Management, Outsourcing, Technical Training and Regulatory ComplianceDrug stability: Pharmaceutical analysis and validation and transfer.Technical knowledge across multiple disciplines of drug development.In depth knowledge of drug stability, cGMP/GLP and method development and validation.Experience with current FDA regulations and compliance, ICH, and global requirements, cGMP/GLps, CMC, IND, NDA, sNDA and annual reporting.Experienced addressing commitments related to FDA Consent Decrees.National and international oral presentations on "Stability" an...

Dissolution and HPLC Expert with Big Pharma Laboratory Management Experience - Technical Consultant #1558

Pharmaceutical Consultant Specializing in Drug Dissolution, Liquefaction, Laboratory Management and Regulatory ComplianceDissolution (reduction to a liquid form; liquefaction) method development, validation, transfer and troubleshooting.HPLC method development, validation and transfer.Laboratory instrument qualification and calibration.GMPs/ICH/USP: laboratory Quality Assurance and regulatory inspection readiness.Regulatory specification development.Preparation of the CMC (Chemistry, Manufacturing and Controls) section of IND (Investigational New Drug) and eCTD (Electronic Common Technical Document).Development of SOPs and Quality System...

Expert in Size Exclusion Chromatography (SEC) and Applications in Pharmaceuticals - Technical Consultant #1619

Analytical Chemistry Consultant for Size Exclusion Chromatography (SEC)SummarySize Exclusion Chromatography (SEC, also known as Gel Permeation Chromatography, GPC) and its application to the compositional and failure analysis of polymers for pharmaceutical, medical device and the chemical Industry. Specific SEC experience includes:Molecular mass distribution (MMD) of natural and synthetic polymers, blends and oligomers.Analytical method development, validation, transfer, stability studies, quality control, cleanup and release testing procedures.Environmental resistance of polymers, including chemical exposure, oxidative resistance, weathe...

Expert in CMC and Regulatory Submissions for Health Authority and FDA - Technical Consultant #1620

Drug Analytical Support Consultant with CMC and Consent Decree ExpertiseAssessing specification and CMC analytical development for pharmaceutical drug substances and drug products.Analytical project planning and strategies for early, mid and late stage development programs.Writing, editing, and reviewing analytical technical reports.CMC and regulatory submission documents for Health Authority and FDA responses.HPLC method development, validation and transfer.Subject matter expert for the isolation and identification of synthetic impurities and degradation product unknowns.Contract Research Organization (CRO) management.Analytical Investiga...

Pharmaceutical Expert Specializing HPLC and Size Exclusion Chromatography: Pharmaceutical Compliance and Quality Control - Technical Consultant #1636

Drug Stability and Drug Quality Consultant and Analytical ChemistProduct experience includes brand, generic and drug substance (active pharmaceutical ingredient, API); small molecules, biologics, vaccines; Rx and OTC products; oral, topical, and parenteral dosage forms.Pharmaceutical compliance and remediation, quality systems management, data integrity audits, product quality assessments, gap assessments, batch reviews, laboratory and manufacturing oversight.Authoring of policies, procedures, training programs. Technical and business writing, editing, and proofreading: Proposals, quality agreements, standard operating procedures (SOPs), p...

Pharmaceutical Drug Development Expert Specializing in FDA and ICH Quality and Compliance - Technical Consultant #1646

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.