Pharmaceutical , Medical Device, Cosmetic, Food Regulatory Compliance Expert

Technical Consultant #2228


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

Honors & Publications

Credentials

  • Post Graduate Diploma and Certificate. Regulatory, Quality and Clinical, Academy of Applied Pharmaceutical Sciences, Toronto, ON Canada
  • Online literature databases used: Pubmed, Pubmed Central, MEDLINE, EMBASE, Cochrane

Publications and Patents

  • Various regulatory articles published by global regulatory associations including Canada's CAPRA (NOC Magazine and bi-weekly e-Bulletins), USA's RAPS (Regulatory Focus) and UK's TOPRA (Regulatory Rapporteur).

Education

  • B.S. Life Sciences Human Biology (With Honors), University of Toronto, Ontario, Canada
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