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Regulatory Submission Experts for FDA, PMDA, EMA & More

Accelerating Clinical Submissions Through Define.xml Excellence

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Define.xml is a critical component of regulatory submissions for clinical study data, providing machine-readable metadata that describes datasets—such as SDTM, SEND, ADaM, and BIMO—to facilitate regulatory review. Ensuring strict compliance with the latest CDISC standards and the regulatory guidelines set forth by authorities like the FDA, PMDA, NMPA, and EMA is essential, yet creating and validating Define.xml can be complex, error-prone, and time-consuming when done manually.

At Maha Tech, we specialize in streamlining this process with our expert services

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Regulatory Submission Experts for FDA, PMDA, EMA, NMPA& More

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