OTC / RX / Biotech

Unlike prescription medications that can only be accessed with a medical prescription, OTC pharma are available for purchase without a prescription, on store shelves in pharmacies and other stores, such as supermarkets or small convenience stores.

The switch from prescription to over-the-counter is a strategy designed to extend a pharmaceutical product’s commercial life. Yet, once an active ingredient has been designated to OTC, scores of similar products may emerge from it, including one or more bearing the original brand, private labels, and combination products.We can conduct a wide range of pre-clinical efficacy and safety tests on OTC/RX/Biotech products.

Explore our services:

  • Relative & Absolute bioavailability;
  • Multiple dose/Steady state studies;
  • Dose escalating studies;
  • Food & Drug interaction studies;
  • Pharmacokinetic studies;
  • Dispensing/Compounding pharmacy.

Rx-to-OTC switch services

An Rx-to-OTC switch is the process by which a prescription medication moves from prescription to over-the-counter status for either the same or a related use. Data to support the switch are derived from randomized, controlled clinical trials submitted in the original prescription, as well as years of post-marketing safety surveillance and literature reports. In addition, new efficacy and safety data from controlled clinical trials are included in the switch application if the OTC indications or strength differ from those for the prescription drug product. An assessment of ease of understanding of the product information is included in the switch application as well.

SPRIM can support the Rx-to-OTC switch process through the implementation of:

  • Efficacy and safety clinical services, from Phase I to Phase IV and post-marketing trial;
  • Consumer and patient behavioural and perception assessment;
  • Regulatory services on label design;
  • Comprehension studies on label, drug facts, package insert and supplemental materials.

our publications & case studies

Discover our latest scientific publications