When one thinks of an industry poised for the exceptional year over year growth, often they think of the biotechnology sector. The medical device and drug-device category is currently a multi-billion dollar industry with substantial growth potential. This market is primarily driven by the growing desire for patients and providers to deliver minimally invasive procedures. Other benefits include improved tolerance levels, simplification of dosage regimen, and improved symptomatic and pharmacokinetic profiles.

According to the FDA, a drug-device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or another similar or related article, including any component, part, or accessory,  which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. 

Drug-Device Testing With ChRi

The purpose of drug-device testing is to select product candidates, ensure the patient is not placed at undue risk, and provide a reasonable probability that the product intended for treating a specific condition will demonstrate efficacy. Understanding that on average, a drug-device takes about 12-17 years from the initial phase to FDA approval, ChRi believes that each moment wasted compromising patient care.

ChRi blends expertise, high standards, and FDA guidance documentation to ensure that your product meets the proper standards. Our dedication to our clients consists of a customized drug delivery device testing that is catered to the needs of our clients. Some of our services include:

  • Biocompatibility Testing
  • Container Closure Integrity
  • Environmental Condition Testing
  • Shelf-Life Stability and Expiration Dating
  • Comprehensive Drug Delivery Services

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