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Specializing in FDA regulatory compliance software, services, and submissions for Structured Product Labeling - SPL. This includes Product Labels, Labeler Code Requests, Establishment Registration, Lot Distribution Reporting - LDR, Risk Evaluation and Mitigation Strategy - REMS, Generic Drug Facility Identification - GDFI and Physician Labeling Rule - PLR. We service Individual Case Safety Reports - ICSR, Electronic Medical Device Reporting - EMDR, and Electronic Common Technical Document - ECTD as well. We also provide mission-critical quality, compliance and risk assessment applications. We supply unique solutions for enterprise resource management and issue resolution. In addition, we provide AS2 automated FDA submission services.
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