Evaluation of a Health Care Antiseptic Drug Product
For more than 26 years, Microbac's Microbiotest Division has maintained a resolute commitment to exceptional laboratory analysis and outstanding customer service. Today our company continues to be universally recognized within the disinfectant, antiseptic, and bioprocess industry, a distinction derived, and nurtured, by providing the best services possible to all our clients.
In the development of antiseptic skin products, in vivo studies play a critical part in gaining FDA approval. The selection of a testing laboratory to conduct these crucial tests should take into account the experience, performance, and credibility of the contract laboratory. Microbiotest is the ideal choice because performance, data integrity and quality assurance are the foundation of the tests performed at our laboratories.
- A stand-alone clinical facility to perform your in vivo trials
- A Principal Investigator, who received a perfect FDA 483 for his last audit
- An internal Institutional Review Board (IRB) to offer quick, accurate protocol approval while protecting the confidentiality and safety of its volunteers
- An excellent database of diverse human subjects (currently more than 1,000)
- A large inventory of laboratory grade and clinical isolates
- Exceptional turnaround time
This summary provides a general outline of the recommended efficacy in vitro and in vivo evaluations with the current requirements by the US Food and Drug Administration.