Quality Control & Regulatory Compliance

Our facilities follow current Good Manufacturing Practices (cGMPs) and are routinely audited to ensure that we are meeting and exceeding the highest standards required by our clients, the Food and Drug Administration (FDA), and Health Canada.

  • Health Canada and FDA approved facilities
  • cGMP Compliant Certifications from 3rd parties such as Intertek and UL
  • Pharmaceutical Establishment Category IV license for manufacturing drug (DIN) products
  • Site license for manufacturing and packaging of Natural Health Products (NPN)
  • Category II Medical Device Distribution license

A Premium and Reliable Product

Quality Control

We perform physiochemical testing of incoming raw materials and packaging.

Our in-house analytical laboratory capabilities including:

  • In-process and release testing using FT-IR, CEM, titration, and GC
  • Test method development and validation
  • Real-time and Accelerated Stability studies using validated stability chambers and test procedures

Regulatory Compliance

Our highly experienced staff are available to assist with all aspects of regulatory compliance. For example:

  • Labeling and nomenclature as per FDA labelling regulations for OTC and Cosmetics
  • Claim substantiation review and testing in accordance with FTC, FPLA, and FDA guidelines
  • GHS-compliant documentation including, but not limited to, SDS, ADPR, and ANDA documents
  • International registration assistance including Certificates of Free Sale, Certificates of Origin, Notarizations, and Apostiles