Regulatory affairs

  • Evaluating the acceptability of pharmaceutical, natural health products and cosmetics formulations.
  • Writing and\or evaluating product labels.
  • Developing marketingstrategies for new products.
  • Preparing and submitting to Health Canada marketing authorization (NDS, S/NDS, ANDS, NC, DIN, NPN).
  • Preparing and submitting to Health Canada medical device license applications.
  • Negotiating with Health Canada for the approval of new products.
  • Preparing and submittingresponses to clarification requests raised by Health Canada.
  • Preparing and submitting establishment and site license applications.
  • Quality control

  • Writing standard operating procedures.
  • Preparing manufacturing and packaging master files.
  • Sampling and testing packaging material.
  • Sampling and performing visual inspections on finishedproducts.
  • Verifying and approving production documents.
  • Performing product release.
  • Managing stability studies.
  • Assurance control

  • Auditing Canadian and foreign suppliers.
  • Performing self-inspections according to Good Manufacturing Practices.
  • Coaching companies in preparation for Health Canada inspections.
  • Representing companies during Health Canada inspections.
  • Pharmacovigilance

  • Receiving and evaluating adverse effects.
  • Performing literature search.
  • Preparing annual summary reports.
  • Performing signal detection and safety issues.
  • Performing self-inspections according to Good Pharmacovigilance Practices.
  • Coaching companies in preparation for Health Canada inspections.
  • Representing companies during Health Canada inspections.
  • Training

  • Good Manufacturing Practices (GMP).
  • Good Pharmacovigilance Practices (GVP).
  • Drug development.
  • Academic training.
  • Other services

  • Preparing and submitting product registration to Pest Management Regulatory Agency.
  • Writing and\or evaluating food labels.
  • Preparing and submitting license producer’s application under the Access to Cannabis for Medical Purposes Regulations (ACMPR).
  • Consulting

    Targeted products
  • Pharmaceutical
  • Veterinary
  • Biological
  • Natural health
  • Cosmetics
  • Medical devices
  • Medicinal cannabis
  • Other
  • Nathalie Lebel: consulting services to pharmaceutical and parapharmaceutical companies, Regulatory Affairs, Quality Assurance and/or Quality Control departments.
    Nathalie Lebel: consulting services to pharmaceutical and parapharmaceutical companies, Regulatory Affairs, Quality Assurance and/or Quality Control departments.
    years in business
    % success rate
    business start-up
    GMP & GVP inspections
    DIN & NPN applications
    Lebelpharma: pharmaceutical consultant: consulting services to pharmaceutical and parapharmaceutical companies, Regulatory Affairs, Quality Assurance and/or Quality Control departments.
    Lebelpharma: pharmaceutical consultant consulting services to pharmaceutical and parapharmaceutical companies, Regulatory Affairs, Quality Assurance and/or Quality Control departments.
    Lebelpharma: pharmaceutical consultant consulting services to pharmaceutical and parapharmaceutical companies, Regulatory Affairs, Quality Assurance and/or Quality Control departments.
    Lebelpharma: pharmaceutical consultant consulting services to pharmaceutical and parapharmaceutical companies, Regulatory Affairs, Quality Assurance and/or Quality Control departments.
    Lebelpharma: pharmaceutical consultant consulting services to pharmaceutical and parapharmaceutical companies, Regulatory Affairs, Quality Assurance and/or Quality Control departments.
    Lebelpharma: pharmaceutical consultant consulting services to pharmaceutical and parapharmaceutical companies, Regulatory Affairs, Quality Assurance and/or Quality Control departments.