Quality Systems & Compliance

Build and maintain the systems that keep your products safe, legal and reputationally sound.

• QC Lab Setup & SOPs
  – Lab design, equipment specs and procurement guidance
  – Standard Operating Procedures and method validation

• Regulatory Strategy & Licensing
  – Health Canada (NNHPD), FDA, CE-marking and international registrations
  – Dossier preparation, submission and agency follow-up

• Quality Management Systems
  – ISO 9001, HACCP, GMP gap analyses and implementations
  – Internal audits, corrective action and continuous improvement

• Batch Release & Validation
  – Analytical method validation and release testing protocols
  – Stability-testing program design