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Pharmacovigilance and Risk Management

30 Mar 23

Challenge

A company with a major marketed oncology product loses the Lead Clinical Safety physician, threatening defence of the label at EMA and FDA and further development plans.

Solution

tranScrip provided at short notice a highly experienced oncology drug safety physician, who assumed global safety leadership.

Result

The development programme was able to continue and the label extensions were successfully negotiated with the regulatory agencies.

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Our experienced physicians and scientists, together with our regulatory, clinical and commercial experts can support you to maximise the value of your products. Whatever your project requires, we have the expertise to meet your needs.