Regulatory guidance to help your organization with response, remediation planning, and preventative measures.
Whether you’ve just been issued a 483 following FDA inspection or a warning letter due to a breach of FDA regulations, there is no time to delay. A point-by-point detailed response or remediation letter must be submitted immediately to avoid further penalty. From informative consulting to full-service strategy, let our regulatory experts help develop a customized plan for your FDA response needs.
Check out our case study about USDM Life Sciences supported a large scale remediation effort reassessing nearly 2,000 GxP software applications in the wake of unsavory FDA audit findings.