Licensing
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Advising on complex bioequivalence issues
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Assessment of new trial data to support MAA re-submission
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EMEA follow-up measure / specific obligations responses
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Evaluation of Competent Authority / EMEA turndowns, response compilation, identification of deficiencies and how to address these
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Providing critical reviews for US clients wishing to license in Europe
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Reporting of inappropriate competitor regulatory behaviour
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Review of clinical documentation of anti-cancer agents
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Reviewing Clinical Overviews
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Reviewing IND documentation
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Risk Management Plan overview
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Risk Management Plan preparation
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Signing off generic application non-clinical and clinical overviews
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Safety data support and review
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Writing annual renewal Clinical Overview