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...

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...

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, 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...

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...

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...

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...

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: 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.

Analytical Chemistry Consultant for Drug Development, Drug Identity and Expert Witness for Patent LitigationDrug development focused on chemistry manufacturing and control for drug substances and drug products.Analytical method development, validation, technology transfer, trouble-shooting.HPLC, GC, chiral analysis, other separations techniques, trace analysis.Physical property and solid state characterization, polymorphism, crystal form, particle size.IND, NDA, CTD regulatory document preparation, briefing documents for end-of-phase 2 meetings, pre-NDA meetings, responding to regulatory questions.Pharmacopeial monograph development, ant...