HomeOTCs & Pharmaceutical Consulting
Move ahead in the OTC market with the best experts
Like natural health products, over-the-counter medications are strictly regulated, though the return on investment justifies the resources spent in regulatory compliance. We provide the support you need to make and market your brands in this competitive industry. Our services include drug classifications, drug facts panels, compliance review and more.
OTC Services for the United States
- Drug classification (monograph vs. new drug; prescription vs. non-prescription)
- GRASE conditions review
- Drug facts panel creation
- Preparing 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
- Creating compliant draft labels
- Adverse event reporting
OTC Services for Canada
- Drug classification (labelling standard vs new drug; prescription vs non-prescription; disinfectants)
- 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)