Nathalie Lebel, consulting

Regulatory Affairs

Quality Assurance
/Quality Control

Training

Regulatory
Affairs

  • Evaluation of product formulation (pharmaceutical products, natural health products, cosmetics)
  • Creation and/or evaluation of product label
  • Developing strategies to market new products
  • Preparation of regulatory submissions (NDS, S/NDS, ANDS, NC, DIN, NPN)
  • Preparation of medical device licence applications
  • Negotiation of marketing licence approval with Health Canada
  • Preparation of answers to clarifax and other product licence related questions from Health Canada
  • Preparation of Drug Establishment Licence and Site Licence applications

Quality Assurance
/Quality Control

  • Redaction of standard operating procedures
  • Creation of master manufacturing and packaging records
  • Sampling and analysis of packaging materials
  • Sampling and visual inspection of finished products
  • Review and approval of batch records
  • Release of finished products
  • Audit of suppliers (Canadian and foreign suppliers)
  • Self-inspection (GMP and PV)
  • Preparation of companies to Health Canada inspections
    (GMP and PV)
  • Participation during Health Canada inspections

our
training

  • Training on Good Manufacturing Practices (GMP)
  • Training on pharmaceutical drug development
  • Employee training as per our client’s needs

  • Academic training