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Regulatory Handshake

Regulatory Support

Submission
Preparation / Review

At Quality Confidential, our consultants are ready to assist your company with regulatory submissions, at all phases of product development. Our regulatory experts have completed projects of every size, from copy review for artwork and inserts to CMC review, application completion, and electronic submission. Let our experts assist you in creating a roadmap to submission completion.

Global Labeling/
UDI Requirements

With the rise of drug and device counterfeiting worldwide, new laws have been passed globally requiring unique identifiers to be included in drug and device packaging. For medical devices, the FDA has established and continues to implement a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Quality Confidential has expert consultants that have implemented UDI requirements for large, global medical device companies. 

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