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Regulatory Publishing for the US

Client Background:

The manufacturer is one of the global producers of cancer medicine which is intended to treat cancer patients.

Client Problem:

Manufacturer needed support for End – To- End services to catalyze the submission process Submission ready documents (Publishing related activities).

ND Global Solution & Approach:

ND Global developed the Submission ready documents (Publishing related activities) with more than 95% quality and, organized review. The customer received a thorough review from us and consultation support to close any gaps.

Project Achievements:

Based on their positive experience, the customer extended the scope of work to seek support for future products.

Project Outcomes:

The USFDA accepted them without making any observations.

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