Over-the-Counter Drugs and Scientech Labs

Over-the-Counter (OTC) drug products are regulated by the FDA to assure their potency and safety for Consumers. The FDA also requires stability studies to justify shelf life and expiration dates on these products. Scientech conducts precise quantitative analyses of active ingredients by HPLC, GC, and other methods to provide manufacturers and Brands with data to support their product launches and batch releases. Scientech also has facilities to conduct stability studies under real time, accelerated, and Zone IV conditions. Scientech’s Quality Program assures the accuracy and cGMP compliance of all data and results.

  • Method Development and Validation in 2-3 weeks (expedited TAT available)
  • Finished Product & Release Testing in 3-5 days (expedited TAT available)
  • Stability Programs (real time, accelerated, Zone IVa, Zone IVb)
  • Testing Support to Accelerate Formulation & Process Development
  • R&D Expertise to Troubleshoot Manufacturing Issues, Contaminant ID & Failure Analysis
  • Method Transfer
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