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Regulatory submission is a critical and often
stressful period in a product’s life cycle. Maximise the
likelihood of a successful outcome by utilising our expert support
during both the filing and approval processes.
| We offer: |
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Production of high quality regulatory
documents, e.g. for submissions and labels |
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Participation in health authority meetings/panels |
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Written responses to questions from regulatory
bodies |
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Advice on health authority interactions. |
| Recent projects: |
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Participation and presentation
in key EMEA meetings leading to the approval of an antifungal |
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Preparation for, attendance and presentation
at an FDA advisory committee meeting for a cardiovascular
drug |
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Written responses to Day 120 questions
for an antibacterial. |
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