Your Pharmaceutical Consultant

Lebelpharma offers consulting services to pharmaceuticals and parapharmaceutical companies, no matter if they possess Regulatory Affairs, Quality Assurance, Quality Control and/or pharmacovigilance departments.

Regulatory Affairs

  • Assessment of product formula for pharmaceuticals, natural health products and cosmetics.
  • Writing and/or assessing product labels.
  • Developing marketing strategies for new products.
  • Preparation of regulatory submissions.
  • Preparation of establishment licence, site licence and cannabis licence producer applications.
  • Negotiating with Health Canada.
Pharmacist holding pill bottle

Quality Assurance & Quality Control

  • Writing standard operating procedures.
  • Preparation of master files.
  • Sampling and testing packaging materials.
  • Performing visual inspection on finished products.
  • Review and approval of production documents.
  • Performing product release.
  • Managing stability studies.
  • Auditing Canadian and foreign suppliers.
  • Performing self-inspections.
  • Representing companies during Health Canada inspections.

Pharmacovigilance

  • Receiving and assessing adverse reactions.
  • Performing literature search.
  • Preparing annual summary reports.
  • Performing signal detection and safety issues.
  • Performing self-inspections.
  • Representing companies during Health Canada inspections.
Paperwork

Cannabis Regulations

  • Preparation of licence applications.
  • Writing standard operating procedures.
  • Act as Quality assurance person.
  • Representing companies during Health Canada inspections.

Training

  • Good Manufacturing Practices (GMP).
  • Good Pharmacovigilance Practices (GVP).
  • Good Production Practices (GPP)
 
 
Speech of teacher

© 2024 All rights reserved