Analytical chemist specializing characterization and analysis of unknown materials, laboratory operations and REACH compliance, Certified Quality Auditor, CQA,Specialize in the analytical in-process / laboratory problem resolution and cGMP auditing / compliance and gap analysis of pharmaceutical suppliers.Process analytical technology solutions and project management.Preparations for REACH compliance in the European Union (EU).Established a satellite pharmaceutical testing laboratory in Hyderabad, India.Pharmaceutical ingredient supplier (cGMP) auditing (ASQ-CQA) including quality systems and regulatory affairs.Qualification of Asian sun...

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 R & D consultant specializing in strategic and operational planning, safety assessment, toxicity study protocols and re-engineering.Pharmaceutical research and development methodology.Pharmaceutical research and development portfolio strategy and management.Drug development modeling, scenarios and matrices for decision support.Re-engineering and R&D core business systems; R&D budget and resource forecasting.Pharmacoeconomics, health outcomes and disease management.New Chemical Entities (NCE) drug development.Phase I to Phase IV drug pre-clinical and clinical safety assessments.Pharmaceutical IND, NDA and ANDA registrations....

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...

Past FDA Employee Expert in Food, Drug, and Medical Devices Safety and Regulatory ComplianceFDA inspection and investigation of medical devices, pharmaceutical, biologics and food facilities to enforce the FD&C Act.Conducted international FDA medical device and pharmaceutical inspections in 18 countries.Medical device Quality System and pharmaceutical cGMP regulations and principles.QS regulation inspections of the following types of medical device process technologies: Electronic/electrical, sterile (ETO, dry heat, steam, irradiation), plastic, in-vitro diagnostic, metal CNC machining and a variety of product types.Pharmaceutical cGMP re...

Dosage From Pharmaceutical Consultant: Facilities Management and GMP ComplianceFormulation and process development of multiple types of pharmaceutical dosage forms.Research and development, optimization, manufacturing and packaging of solid, liquid and powdered dosage forms.Scale up and technology transfer of multiple dosage forms.Equipment and processing knowledge, product processing/equipment trouble-shooting and facility validation and qualification activities.Identifying and implementing significant operational cost savings in pharmaceutical operations.Auditing of diverse cGXP operations (API manufacture, laboratory operations, clinica...

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.

Pharmaceutical Quality Auditor: Excipient GMP auditing, International IPEA, and ISO standards, 9001, 17025, 14065Certified Quality Auditor with 20 years experience of working with quality systems.Trained in a number of ISO standards, Pharmaceutical Excipient GMP auditing and is an approved auditor for International Pharmaceutical Excipients Auditing (IPEA).Experienced with ISO 9001, ISO 17025, ISO 14065 and Lexcel, Law Society's practice management standard.Undisclosed Company, Director, 2008 - PresentA consulting firm servici...