Regulatory Services

Is regulatory for orphan drugs in rare diseases different from traditional drugs?

Yes, drug development in rare diseases, unlike traditional drugs, involves special considerations and regulatory approaches such as financial benefits, faster approvals, and less stringent clinical data requirements.

We understand various regulatory approaches with our regulatory expertise and practical knowledge in obtaining orphan drug designation and market approvals.

Learn more on various regulators providing incentives in rare disease drug development

Rare disease regulatory incentives in United States & Europe

Rare disease regulatory incentives in Japan & Australia

Rare disease regulatory incentives in Asian countries

What services does Credevo provide?

Credevo offers all type of services right from preclinical to market approvals of Orphan drugs in rare diseases.

  • Pre-clinical & Clinical regulatory services
  • Dossier compilation guidance, submissions
  • Marketing authorization guidance

In which countries does Credevo provide the regulatory service for rare diseases?

Developing drugs for rare diseases is financially not viable unless the drug or medical device receives an orphan drug designation and regulatory incentives.

Choosing a country that supports rare disease drug development is advisable, and Credevo provides regulatory services in countries that are feasible and support rare disease drug development.

What are the other services other than regulatory does Credevo provide?

We also provide services other than regulation in rare disease drug development such as

  • Comparator shipment
  • Special rare disease clinical trial feasibility services
  • Clinical trial monitoring services
  • Find clinical investigators for your rare disease orphan drug trials

For queries, contact us at [email protected]