By: Regulatory Solutions  09-12-2011
Keywords: drug, Audits, Natural Health Products


Regulatory Solutions, founded in 2001, obtains strategic and innovative Regulatory Affairs approvals from Health Canada in a time sensitive manner. I also assist in your company’s post-marketing changes and provide excellent GMP and Quality System services.

Regulatory Solutions has obtained numerous new (branded) and generic drug approvals in the Canadian marketplace. I have also served clients in the United States and Europe in obtaining Canadian regulatory approvals.

In addition, I have obtained Class II, III and IV medical device approvals as well as natural health products (vitamins, minerals) which are now regulated in Canada under a separate division at Health Canada.

I have set-up and administered several quality assurance systems and regulatory affairs departments for foreign companies that have located to Canada. I have helped companies to obtain Drug Establishment Licences for operation in Canada. As well, I have supervised a variety of GMP audits of Canadian facilities.

In addition, I have represented several clients in due diligence matters concerning the licensing or sales of their approved pharmaceutical products to another manufacturer.

Since 1993, I have worked with the people at Health Canada as well as the local inspectorate- who are responsible for Good Manufacturing Practice (GMP) audits for both drug importers and distributors.

Here is a list of Services that I provide:

Pharmaceutical Regulatory Affairs

  • Time Sensitive Strategic Regulatory Planning
  • Prepare and File CTA’s (Clinical Trial Applications)
  • Prepare and File NDS's (New Drug Submissions)
  • Prepare and File Abbreviated New Drug Submissions (ANDS)
  • Prepare Drug Identification Numbers (DIN) Applications
  • Submission Support during TPD reviews
  • Post-Approval Changes (SNDS, Notifiable Changes or Updates)
  • Provincial Formulary Submissions
  • Review and Consult on Product Labels and Advertising
  • Prepare, File and Obtain Drug Establishment License (DEL) Applications and Natural Health Product Site Licence Applications.
  • Organize and Advise during Due Diligence Audits

OT C and Natural Health Products

  • Time Sensitive Strategic Regulatory Planning
  • Prepare Drug Identification Numbers (DIN) Applications
  • Prepare Natural Health Product Applications (compendial and non-compendial)
  • Review and Consult Product Labels And Advertising

Medical Devices

  • Time Sensitive Regulatory And Strategic Planning
  • Prepare and File Class II, III and IV Applications
  • Confirm Classification of Class I medical devices
  • Provide Submission Support During TPD Review
  • Review and Consult on Product Labels and Advertising
  • Advise on Regulatory Compliance Issues

Good Manufacturing Practices (Importers and Distributors)

  • Supervise Canadian Required QA - QC - GMP Activities and Systems
  • Organize and Supervise Compliance Audits with TPD Inspectors From Start to Finish.
  • Provide Time Sensitive and Strategic Consultation on Compliance Issues
  • Write Standard Operating Procedures (SOP) documents- including ADRs, Complaints Handling, and Product Recalls
  • Organize and Supervise During Due Diligence Audits
  • Supervise Vendor Audits
  • Provide Training in GMP for importers and distributors
  • Advise on Method Validation Transfer Protocols

Keywords: Audits, drug, Drug Approvals, Generic Drug, Natural Health Products,

Contact Regulatory Solutions

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