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Design Control, Audit, Remediation
Audit Design Control activities for development of a combination product (Injectable pen) and implement a remediation plan for large drug company. |
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Mr. Bacchus provided excellent support towards to the completion of our Design History File for the development of our injectable drug product. Through his support our firm was able to clearly define the contents of the DHF, as well as develop the necessary CMC documents to transfer the design to the contract manufacturer. |
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