SAVIENT definition
Examples of SAVIENT in a sentence
Such data will be prepared and sent to SAVIENT within thirty days of the end of the review period.
If such documentation is not reasonably acceptable to SAVIENT, BTG will cooperate in taking such steps as SAVIENT may reasonably require to ensure that the documentation, and any Processing described therein complies with the Bulk Product Specifications and all Legal Requirements.
SAVIENT QA and Manufacturing will then review the documentation and notify BTG whether or not documentation is acceptable.
Following review and acceptance by BTG QA, BTG will send copies of these documents to SAVIENT QA.
Observation by SAVIENT or its authorized representative shall be governed the following.
Changes to such documents must be signed by authorized representatives from SAVIENT Quality Assurance, SAVIENT Manufacturing and SAVIENT Regulatory Affairs.
When a deviation has occurred, SAVIENT will have the final review and decision making responsibility as to the impact of the deviation on the Bulk Product or Product, which will include the disposition of affected lots.
The frequency and duration of any additional visits must be agreed to by SAVIENT and BTG.
BTG shall reasonably cooperate with SAVIENT and regulatory agencies regarding an investigation or inquiry that may be initiated by a regulatory agency or otherwise required in response to a consumer or healthcare professional.
At SAVIENT’s request, BTG shall conduct such additional or more detailed investigation of the deviation as SAVIENT may reasonably instruct.