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Regulatory Strategies & Plans
All developments of drugs and line extensions have one final goal - regulatory approval and entry into the market. There are several ways to develop a drug, a new indication, or a line extension. As all ways are expensive and time-consuming, it is important to create a road map of development at the outset. This road map should contain the following elements:
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Chemical, pharmaceutical and manufacturing development
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Regulatory issues and pitfalls
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Assessment of all relevant legislation and guidelines for the target market (e.g. Europe, United States)
We prepare full regulatory plans and strategies (road maps) taking into consideration the relevant legislation and emerging trends for:
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