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Regulatory Strategy


A Regulatory Strategy is a key component of every product development. It is important that the Regulatory Strategy be developed very early in the drug-development process and to be revisited in regular timeframes.

Phortas can help you prepare the appropriate Regulatory Strategy and document it in a way that fully takes into account your product characteristics, appropriate legislative, market conditions, country/region requirements, desired label claims, targeted submission/approval dates, regulatory risks, etc.

Contact us at and together we can define the best approach to support you in reaching your goals.
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