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.

Software Validation and Quality Consultant for FDA ComplianceAuditing for ISO 13485, FDA QSR, ISO 9001, MDD and IVD, CE mark.Specialist on FDA regulated industries and software validation requirments.Process validation, software validation, Part 11, GMP development, ISO 13485 development.FDA response and remedial actions, quality systems creation, quality systems improvement.Creation of technical course and leading training groups on FDA-QSR and Software Quality, including training effectiveness assessments.FDA quality documentation, risk management, specification development and sampling plan analysis and rationale.

Pharmaceutic Analytical Chemistry Consultant Expert in Drug Stability and Identification of API and Chemical Materials, (Pharmaceutical Chemist Expert on Forced API Degradation Studies and Drug Stability)Leadership of multi-scientist group responsible for the analytical characterization of drug substance and drug product formulations.Analytical method development and validation, drug substance and drug product characterization, stability evaluation, and analytical research and development project management.Broad background in the areas of physical-organic chemistry and analytical chemistry, chromatographic (HPLC, GC, SEC, Chiral) and spe...

Experienced pharmaceutical laboratory manager and analytical chemist with expertise in GLP and GMP compliance and solid dosage forms.Extensive experience in pharmaceutical, nutraceutical and chemical industry analytical laboratories.Laboratory management and analytical laboratory improvement, cGMP and GLP compliance and problem resolution.Pharmaceutical process, cleaning and analytical methods validation.Solid dosage for OTC drug products.Responsibility for QA/QC functions for testing, complaint handling, customer audits and data analysis for over 300 different drug products.Training on cGMP and GLP compliance and problem resolution.Docume...

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...

API Quality Assurance, SOPs, batch production records and protocols, CAPA and SMF Activities, Clean Room ValidationsCompliance to cGMP Systems and Regulatory requirements. Application risk assessment, as applicable at various QMS documentation. Review of all the SOPs, batch production records and protocols (validation and qualifications) prior to the approval along with change request forms. Review of all equipment qualification documents like reactors, centrifuges, different types of dryers, blenders, powder process equipment etc., (DQ, IQ, OQ, PQ) and related test reports. Review of clean room HVAC qualification documents and relat...

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...

Dietary Supplement and Functional Food Consultant Specializing in NPD Innovation and Quality/GMP ComplianceNatural product development and formulation; vet new product opportunities: Navigating IP infringement avoidance, scientific validation, efficacy, dosage, market viability, and regulatory compliance. Natural product ingredient assessments, technical review, and scientific approval. Provide marketing content, direction and guidance for new product launch. New product positioning and marketing strategy, product naming and tag line creation. Natural product: Product quality and marketing integrity: IP protection, regulatory complia...