AxSource Consulting Inc.

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#114-1660 North Service Rd. E.
Oakville, Ontario
L6H 7G3

Our Services include but not limited to : Regulatory Strategy; Regulatory & Clinical (e.g. CMC, NDS, ANDS, CTA, IND/ITA, 510K, PMA) to FDA, EMA, MHRA, Health Canada, TGA); eCTD Services; Site & Product Licensing including Dealer’s License; Quality & Compliance services (ISO 13485, GLP, GCP, GMP, GVP, GDP, GXP Training, Inspections, QMS and Audits);Pharmacovigilance; Facility, Equipment, Process and Software Validation.

Product Areas

  • Innovative drugs
  • Generic drugs
  • Biologics/biotechnology
  • Active Pharmaceutical Ingredients
  • Subsequent entry biologics
  • Cosmetics
  • Medical devices
  • Natural health products
  • OTC/non-prescription drugs
  • Drug/device combination products
  • Medical marijuana
  • Veterinary
  • Radiopharmaceuticals
  • Quality & Compliance, Pharmacovigilance and Validation Services including Software

Jurisdictions

  • Canada
  • US
  • Europe (EU)
  • Asia
  • Australia / New Zealand
  • Latin America

Contact

Christine Docherty
Executive Administrator
Tel: 905-854-6059 ext 201
christine@axsource.ca
Posted 14-Feb-2019