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Orphan Designations

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

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.

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

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. 

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

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