Biotechnology Services
Process Validation for Viral Clearance |
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Regulatory Support
The larger Covance organization has a world-wide network of employees with experience in regulatory affairs. Using this network and the vast experience of the staff within the Biotechnology Division, we provide clients with superior regulatory support. Process validation staff can provide help with current issues of concern such as validation and robustness of purification steps.
Covance has developed important channels of communication with all the major regulatory authorities around the world, and we have performed numerous studies that have been accepted as part of registration documentation in Europe, Japan, the United States and other economic regions.
Not only is Covance able to provide regulatory support in the design of studies, it has significant experience in the writing of CTX, MAA, IND and PLA/BLA submissions. Process validation data can be provided in a format that can be incorporated directly into these regulatory submissions. While protecting data integrity, we can tailor the format in which the data is presented to best meet client needs. We have the scientific and regulatory knowledge to provide deliverable such as a summary report and a document suitable for direct incorporation into a regulatory submission, e.g. CMC Part VII.
See also our links to regulatory agencies. |
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