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OTCs & Pharmaceutical Consulting

The Over The Counter Medication Experts Since 2002

Although the regulatory oversight may be challenging to navigate and fulfill, both of these markets have consistently proven that the regulatory burdens are well worth overcoming for the return on investment. We provide all of the services you need to enter these markets and sustain a compliant, competitive and lucrative position.

COVID-19 Update: New Product Pathways for Canada & United States

If you are looking for more information on new product pathways available to manufacturers in response to shortages, please read the following articles:
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Health Canada Regulatory Exemptions

Health Canada has recently announced a number of actions they’re taking in the fight against the COVID-19 Pandemic.

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FDA & EPA - Pathways for Products

FDA & EPA have made changes and exemptions to existing regulations in order to assist companies in getting these vital products to market.

OTC Services for the United States

  • Drug classification (monograph vs. new drug; prescription vs. non-prescription)
  • Determine whether your product meets Generally Recognized as Safe and Effective (GRASE) conditions
  • Prepare Drug Facts Panel
  • Prepare 505(b)(1), 505(b)(2), ANDA or OTC drug monograph applications
  • Prescription to OTC switch applications
  • Abbreviated New Drug Applications (ANDA) for generic OTCs
  • Preparation of compliant draft labels
  • Adverse event reporting

OTC Services for Canada

  • Drug classification (labelling standard vs new drug; prescription vs non-prescription)
  • Preparation of Drug Identification Number (DIN) applications
  • Responding to Clarifaxes
  • Preparation of compliant draft labels
  • Filing notifications and amendments
  • Filing Annual Drug Notifications
  • Adverse reaction reporting
  • Pre-submission meetings with the Therapeutic Products Directorate (TPD)

HOW CAN WE HELP YOU?

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