The over the counter (OTC) medicines industry has experienced unprecedented growth on an international scale, with the United States and Canada being no exception.

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.

OTC Services for the Unites 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)