Canadian regulatory affairs expert prepares pharmaceutical and medical device submissions and audits manufacturing quality practicesPharmaceutical Good Manufacturing Practices (GMP) for Canada.Regulatory Affairs Canada, submission preparation.Change control and complaint management.Pre-approval inspections.Pharmaceutical Quality Systems, clinical trial supplies.Qualification and validation: process, equipment, cleaning and test methods.Water for pharmaceutical purposes.Bioanalysis.Adverse event management; deviation and out-of-specification investigations.Sterile product manufacturing; environmental monitoring.FDA, QA, QC, quality assuran...

Pharmaceutical Compliance Consultant: FDA Regulations & Submission with Management Experience at Indian Pharmaceutical CompaniesPharmaceutical quality assurance and regulatory affairs.Skilled in Indian pharmaceutical research and development with leadership positions at Ranbaxy Laboratories, Strides Arcolab, Unilever and Ciba Geigy, all in India.Pharmaceutical GLC and GMC compliance audits, QA operations and regulatory submissions.Pharmaceutical quality control for analytical equipment, method development and validation.Synthesis of active pharmaceutical ingredients (API) and API isolation, identification, impurities and degradation produ...

Specialists and expert witness in silicone medical devices and related chemical, physical, and biocompatibility testing to support 510k, IDE, and PMA submissions.Specialists in the characterization and qualification of silicone medical devices.Chemical, physical, and biocompatibility testing to support 510k, IDE, and PMA submissions to FDA, particularly related to silicone medical devices and silicone applied technology.Pre-clinical chemical testing and evaluation.Testing protocol preparation; testing protocols of silicone based medical devices.Mechanical testing for manufacture of implantable silicone devices.Polymer characterization, spe...

Consultant for drug development for cardiovascular therapeutics and heart failure; experienced as an expert witness.Drug development, specializing in cardiovascular therapeutics.Expert witness and the evaluation of cardiovascular drugs.Drug safety.Medical writing: Protocols, study reports, manuscripts, FDA submission (NDA) briefing documents and investigation of new drugs (IND).Product support-promotional review and medical information.Evaluation of previously monitored clinical studies.Principal Investigator in the following areas:Vasodilator and inotropic drugs.Vasodilator therapy for acute myocardial infarction.Nitrates and hydralazin...

Specialist in pharmaceutical research and development, synthesis and scale up of experiments, anti-cancer drugsBiotechnology and pharmaceutical research and development:Pharmaceutical process research and process development.Multi step organic drug synthesis: Route and reagent selections; literature and patent survey of synthetic routes; synthesis of API or API intermediate to ensure non infringing routes.Skilled at the use of Boron reagents.Drug discovery:Strategies for discovery of new Inotropic agents (synthesis of modified Adenosine Monophosphate) for heart failure.Discovery for synthesis of novel prodrug oligonucleotide for Cytarabi...

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...

Consultant for Medical Device Software and Compliance and ValidationFDA and ISO compliance, particularly for medical devices and related software systems.Quality system auditing.Supplier quality assurance, audits and FDA checks compliance.Software verification and validation.Software project management.Process assessments and improvement.Computerized systems validation.Software risk management.Software life cycle documentation.Quality system training.Independent ConsultantAbbott Laboratories Diagnostic Division, Irving, TX, 1986 - 2009Manager, Division Software Quality Ass...

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 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.

Consultant for Medical Device Validation and Blood Bank Operations and Collection Devices per FDA RegulationMedical device submissions, regulatory affairs related to medical devices and pharmaceutical, good manufacturing practices (GMP) and Quality Systems Regulation (QSR).FDA compliance procedures including process validation, product validation, software validation, warning letters, consent decree resolution, compliance audits, supplier audits and ISO registrations.Extensive and broad knowledge of U.S. FDA quality and regulatory body regulations.Specializing in medical device submissions, regulatory affairs, and Good Manufacturing Prac...