With so much riding on the development of your new drug, any setback with the FDA can be costly. This is especially true for compounds with abuse potential.  NMS Labs can help by expertly designing and conducting your Risk Evaluation and Mitigation Strategy (REMS) study and providing a report that is sound, clear and FDA-ready - from a trusted and unbiased third party.

A Partner You Can Trust

• Experienced:  Our highly-trained team is well versed in formulation development and has supported many FDA submissions.
• Independent:  We provide unbiased assessments, objective opinions and GLP-like protocols to assure credibility with the FDA and other agencies.
• Confidential:  Complete confidentiality is assured.

Replicating Diversion Techniques

We perform a wide range of "kitchen-type" experiments to challenge drug delivery devices to their limits and compare to currently available formulations.  We then take the outcomes and quantitate by LC-MS/MS to measure, evaluate and report detailed and scientifically backed conclusions.

Detailed and Easy-to-Read Reports

• Ready for FDA and other regulatory agencies submittal
• Includes a well-organized table of contents followed by detailed sections and subsections
• Data presented in detailed tables with easy-to-comprehend summary charts

Learn More

More information can be found here.

Call us or email NMS Labs today to talk about your specific needs.

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