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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Response to Agency questions

For a medium sized pharma company

Due to substantial headcount loss of key resource, a medium sized pharma company engaged the expertise of BioVentures Consulting Limited to respond to Agency questions on a marketing authorisation application which had been submitted to the Australian Therapeutic Goods Administration (TGA). The assignment demonstrated BioVentures Consulting Limited’s ability to rapidly become familiar with vast details of information contained in the initial submission, including the content of key clinical and quality modules, and understand the details of the data from the pivotal clinical trials.

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