Pharmaceutical , Medical Device, Cosmetic, Food Regulatory Compliance Expert

Expertise

• Regulatory strategy, pathways and gap analyses.
• Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, and CNF).
• Regulatory compliance product areas: Prescription brand pharmaceutical and biologic, generic, biosimilar, orphan designation, radiopharmaceutical and over the counter drugs, medical devices, natural health products, traditional herbal medicines, dietary supplements, cosmetics, and food.
• Quality compliance for multiple jurisdictions including Canada, U.S.A. and E.U. (GLP, GCP, GMP, GVP quality systems design and management for companies across the global supply chain; batch documentation; annual product quality reviews; process, computer system and package validation; ISO 13485:2003 certification for Class II, III and IV medical devices; technical quality agreements; regulatory agency audit support; supplier qualifications; self-inspections, and personnel training).
• Drug and medical device establishment licensing and facility registration.
• Chemistry, Manufacturing, and Controls (CMC).
• Label and marketing material and social media compliance.
• Clinical trials: (IRB / ERB consulting; study design strategy; product labeling; investigator brochure and informed consent form; case report forms; study protocol, amendments and report; CTA, IND, IDE applications; registration with U.S. clinical trials, government; safety reporting; good clinical practice audit).
• Safety PharmacoVigilance, reporting and risk management for drugs and medical devices (ICSR, SAE, SADR, DSUR, PSUR, PBRER, RMP, MDR, HCP and public communications).
• Medical information and medical writing.

Expert Witness Experience

• Regulatory expert opinion support for corporations (including legal cases due to serious adverse events experienced by patients / consumers involving medical devices and cosmetics).

Experience

Undisclosed Company, Regulatory Consultant, 2008 - Current

Projects

Sanofi Pasteur

• NDS, NDA, BLA (hexavalent combination vaccine)
• International submissions (e.g. Israel) - Chemistry Manufacturing and Controls (CMC)
• U.S. Prior Approval Supplements (PAS)
• E.U. variations

Gopaldas Visram and Co. Ltd.

• Drug Master File (DMF)

Sigmacon LifeSciences Inc.

• Drug Notification Filings (DNFs)
• Drug Establishment License (DEL) application, amendments and annual reviews
• Quality system upgrades
• Quality reviews - Master manufacturing and packaging documents, labeling, stability data, returns, re-packaged drug product, Out of Specifications (OOS), Certificates of Compliance (CoC), Certificates of Analyses (CoA), and Certificates of Manufacture (CoM)
• Batch releases
• Annual Product Quality Reviews (APQRs)
• Attained compliance rating at Health Canada, GMP audits
• Self-inspections of virtually run manufacturer including contract manufacturing facility (Actavis, then Cobalt Pharmaceuticals)
• Annual pharmacovigilance and drug safety reports

Jintronix

• Premarket notifications [510(k)] for 2 device systems (Jintronix Rehabilitation System and Jintronix)
• Design of Quality Management System (QMS) compliant to Health Canada and U.S. FDA
• Facility registration support
• Clinical study design consultation
• Software risk hazard analyses, cybersecurity and validation consulting

Toshiba Medical Systems Corp.

• Pre and post market regulatory activities for Toshiba's Medical Diagnostic Systems (Investigational Testing Authorization (ITA), medical device license applications and amendments).
• Regulatory evaluations of device system changes
• Software validation gap analyses

McArthur Medical Sales Inc.

• Medical Device Establishment Licensing (MDEL) amendments and annual reviews
• Health Canada audit - resolution of issues and closure
• Medical device recall reporting
• Complaint handling
• Mandatory problem reporting

Beaver Medical Corp.

• Medical Device Establishment License (MDEL) application
• Quality system design and development

Andrew and David Wholesale Ltd.

• Drug Establishment License application (DEL), amendments and annual reviews
• Quality system design and development
• Good Manufacturing Practices (GMP) training
• Attained compliance rating at subsequent Health Canada GMP audits
• Self-inspections
• Computer system validation
• Change management
• Business goals support - assessment of requirements for DEL activity upgrade

Regulatory and Quality Consulting Firms

• Laboratory validation project
• Natural Health Product License Application (NHP PLA) research
• Generic drug regulatory (ANDS compilations)
• Regulatory publications on company website
• Clientele projects
• Regulatory expert opinions and legal support

EMD Inc. , Canada, (Merck KGaA affiliate)

Regulatory Submissions (Health Canada)

• Natural Health Product License Applications (NHP PLA)
• Product monograph regulatory updates
• Support with various Drug Submissions (NDSs, SNDSs, CTAs, Clarifaxes)

Medical Information

• Literature reviews and responses to several medical information requests including market competition analyses
• Online literature databases used: Pubmed, Pubmed Central, MEDLINE, EMBASE, Cochrane
• Global and preliminary response documents
• Review of educational, promotional, advertising material for scientific, technical accuracy
• Reviews, PDR Health, Thomson - Scientific, Pharma, Micromedex
• Literature search training presentations

Drug Safety and Pharmacovigilance

• Achieved perfect compliance rating (0 Observations) in Health Canada drug safety audit and maintained compliance in a subsequent corporate audit
• Initiated internal QC audit trail of entire drug safety department
• Substantially increased efficiency, organization and compliance of drug safety department
• Preparation of global and Canadian drug safety and pharmacovigilance master files
• Periodic Safety Update Reports (PSUR)
• Product recalls - Writing health care professional and public communications
• Benefit risk analyses, signal detection and label safety updates
• Monthly compliance reporting
• Writing of SOPs, work instructions, and personnel training
• Assessment and reporting of adverse events to global Drug Safety Health Canada
• Handled all types of adverse events: serious and non- serious, unsolicited and solicited e.g. Patient Services Consumer Call Centre, reports from literature, clinical and marketed products
• Obtained patient consent For HCP follow up, medical confirmation HCP follow up requests
• Liaised with Health Canada, global drug safety, patients, physicians, pharmacists and nurses

Revolymer (UK) Ltd.

• Natural Health Product License Application (PLA) amendments and notifications
• Regulatory change evaluations

Therapure Biopharma Inc.

• Supported Quality Director with various global regulatory and quality requests

University of Western Ontario (UWO)

• Quality system design for Good Laboratory Practices (GLP) compliance with Health Canada and U.S. FDA
• GLP training of UWO Management, Study Director and Staff
• GLP application package to Standards Council of Canada (SCC)

Voreia Industries Inc.

• Cosmetic notifications to Health Canada for over 80 cosmetics
• Label gap analyses for FDA compliance

Fixderma

• Cosmetic label review and gap analyses (17 products)

Quotient Medical

• Cosmetic label review and gap analyses

Bio-K International

• Food regulatory and label compliance assessments (Canada)
• Training of regulatory and quality team on safety reporting with respect to Dietary Supplements (USA) and Natural Health Products (Canada)

United Biopharmaceuticals Inc.

• NHP regulatory gap analyses

Ingredient Depot

• Facility GMP gap analyses and recommendations

Actavis Canada

• Self-inspection

Gamma Dynacare Medical Laboratories

• Self inspection

Ra Chem Pharma Ltd.

• FDA quality observations resolution

Ind-Swift Laboratories Ltd.

• FDA quality audit report