Our Clients

Quality & Compliance Services Inc. and our NHP division, NHP Compliance, have provided NHP services since the NHP Directorate’s formation in 2000. Over the years, we have provided consultation, auditing, regulatory services, validation, training, technical writing, QAP Services ™ (including product release), and lab services to a broad range of clients.

In many instances, we have helped clients respond to specific regulatory demands under stringent time constraints. In others, we have assisted in implementing quality and compliance support systems. In all cases, our hallmark has been professional, timely, and efficient delivery of work that was both accurate and complete.

 

 

 

Clients
 
REGULATORY SERVICES

As NHP Compliance’s regulatory activities often involve products in various stages of development, and client confidentiality is a priority, we do not post a listing of regulatory clients, just a partial list of activities performed. Here is a sampling of some of the ways we have assisted clients with their regulatory needs.


For NHPs, we have:
  • Performed product evaluations to determine submission requirements, confirming the type of Product Licence Applications (PLAs) required
    • Prepared and submitted Site Licence Applications (SLAs) and associated documentation:
      • Quality Assurance Reports (QARs)
      • Quality Assurance Notification Forms
      • Designated Party Authorization Forms

    • Prepared and submitted various types of PLAs:
      • Non-traditional
      • Compendial
      • Transitional (DIN -> NPN transfer)

    • Prepared associated documentation for PLAs:
      • Animal Tissue Form
      • Evidence Summary Report
      • Quality Summary Report
      • Finished Product Specifications

    • Addressed Natural Health Product Directorate (NHPD) queries:
      • Information Request Notifications
      • Processing Deficiency Notifications

  • Transitioned drug (DIN) products to natural health products (NPN) where applicable