What We Do

Strategic Regulatory Executive Support

When it comes to growing your business and making key decisions, you need to know what the true risks are: regulatory hurdles, certifications, enforcement action, and true risk to your timelines, just to name a few. It’s crucial to have a compliance professional at your disposal to give you that perspective during the decision-making process, not after.

In addition, we can help your leadership team truly understand the strength of your supply chain compliance. This gives you a better snapshot of your overall risk to your P&L but also can be utilized to your advantage during contract negotiations.

Satellite Quality Assurance and Regulatory Affairs Services

IQR Consulting can act as your designated Quality and Regulatory department. We can perform your daily operational tasks (eg. traceability exercises, Certificate of Analysis review, positive releases, label review, claims review), alleviating the pressure of having to hire and train your own team. This is a service we pride ourselves on and can tailor it to the size and needs of your company.

Facility Audits

Did you know that the US Food Safety Modernization Act requires companies to audit their suppliers, in addition to testing? If you are using a third-party manufacturer or purchasing ingredients from a supplier, you'll want to know what’s really happening at those facilities. IQR Consulting can be your eyes and ears on the ground – we can conduct these audits for you and report back findings, areas for improvement, as well as conduct a risk assessment.

Establish and Optimize Your Quality Assurance Program

IQR Consulting can be there every step of the way to help you create your very own Quality Assurance program. We have helped clients develop SOPs, Expectation Manuals, organization structure, environmental monitoring programs and more – all from the ground up.

Regulatory Affairs Services

Depending on your target market and product type, your product may need to be registered with a government agency prior to sale. In other instances, you may need to file a notification to an agency instead. Plan on importing products across the border? If so, you may need the appropriate importing license. Does your product have added vitamins and minerals? If so, the FDA and Health Canada have requirements and limitations on how you can fortify your product.

IQR's team of regulatory professionals are well-versed in this space and can help you identify and execute the best strategy to get your product onto the shelf.

Other Quality and Regulatory Services:

• Quality Systems
  • Provide in-house QA support or support for existing QA teams
  • Foreign Supplier Verification Program (FSVP) Compliance
  • Supply Chain Preventive Controls Compliance
  • Preventive Control Plans
  • Establish and maintaining quality systems for conrolled substances
  • Developing SOPs – customizable templates available for purchase
  • Training (annual GMP refresher, new employee training and SOP-specific)
  • Environmental monitoring program
  • Equipment validation and developing calibration and verification programs
  • Process and cleaning validation
  • Develop and maintain finished product testing program
  • Change controls, deviations, CAPAs
  • HACCP plan creation and maintenance
  • Complaint and adverse event investigation and reporting
  • Conducting Annual Product Reviews or Product Quality Review
  • Label and advertisement reviews for food, cosmetics, NHP, dietary supplement, medical devices and drugs
  • Develop and maintain stability program
  • Recalls and mock recalls
  • Self-inspections
  • Acting as lead auditors for clients who require third party audits


• Regulatory Services
  • Product (Device) classification
  • Product licence application (PLA) submissions
  • Drug Identification Number (DIN) submissions
  • Cosmetic Notification Form (CNF) submissions
  • Controlled substances licensing
  • Site licence application (SLA) submissions for Canadian manufacturer, packager/labeler, and importer
  • Foreign Site Reference Number (FSRN) submissions for non-Canadian manufacturer, packager, labeler and storage facilit
  • Drug Establishment Licence (DEL) submissions for Canadian manufacturer, packager/labeler, importer and distributor
  • Medical Device Establishment Licence (MDEL) submissions for Canadian manufacturer, packager, labeler, importer and distributor
  • Veterinary Health Product (VHP) Notification submissions
  • Post market licence amendments and renewals
  • Liaison between your company and government officials during the licensing process to ensure a smooth and most time effective way to product approval
  • Assistance importing products into Canada