Ascendis Sample Clauses

Ascendis. For changes proposed by Ascendis Pharma, a Change Request has to be sent to Medicom. Medicom shall evaluate the change in accordance with Article 6. If reasonably necessary for evaluation of the change, Medicom will ask Ascendis Pharma for additional information, documentation and/or measures and Ascendis Pharma shall perform the required measures and provide the reasonably required information and/or documentation.
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Ascendis. Evaluation of the change by Ascendis Pharma if change request received from Medicom based on the regulatory classification and carried out Risk Assessment (including updates to the Design History File) by Medicom. If necessary, Ascendis Pharma will ask Medicom for additional information, documentation, and/or measures. Ascendis Pharma decides whether the Change needs regulatory approval or not.
Ascendis. The regulatory department submits all necessary documentation to the appropriate authorities. Appendix 7 to Quality Assurance Agreement between Ascendis Pharma and Medicom Innovation Partner a/s

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