Whether it be a short term need to alleviate a backlog or a long term need to provide ongoing services, Ardent Consultants partners with clients to provide the experience and expertise for ongoing. We offer Quality services in the following segments of Quality Operations:

  • Quality Assurance & Compliance
  • Audits
  • Training
  • Standard Operating Procedures

Our Consultants have the knowledge and experience in management of quality and manufacturing operations. They can support management by providing advice and mentorship. Be it a current operation or a new start-up we can partner with you and provide our expertise. We offer the following:

  • Project Management
  • Process Improvement

The regulatory expectation is that equipment, control systems and processes used to fabricate, store, distribute and test health products need to be qualified and validated. We have experienced and knowledgeable consultants who can ensure that all qualifications and validations are properly carried out and documented. Our consultants are experienced in the following:

  • Equipment and Systems Qualification
  • Shipping Route Qualification
  • Thermal Mapping
  • Cleaning Validation
  • Process Validation

Prescription and non-prescription drugs, Natural Health Products, Cosmetics and Class II, III and IV Medical Devices all need to have product licences. For example prescription and non-prescription products have a product licence typically referred to as a Drug Identification Number or DIN.

Businesses performing any regulated activities such as fabricating, packaging, distributing, importing, wholesaling and testing of any of the aforementioned health products need to have specific site establishment licenses. Our consultants provide their expertise and support to clients on the following:

  • Establishment Licences
  • Prescription Drugs
  • Natural Health Products
  • Cosmetics
  • Product Registrations
  • OTC (non-prescription) Drugs
  • Medical Devices

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