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Development of medicines for rare diseases or "orphan medicines" requires a unique development approach that depends on type of disease and its prevalence.

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Understanding the Regulatory environment related to orphan medicines and its characteristics can help companies streamline the development program and bring orphan medicines faster to the patients.

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One of the first steps in entering the orphan medicines Regulatory framework is obtaining an Orphan Designation from respected Regulatory Authorities. 

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Phortas can help you prepare, submit and obtain an Orphan Designation as well as advise on general development strategies related to the development of orphan medicines. 

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

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