Clinigen supported a UK-based company in securing market authorisation for a niche generic product in 11 EU markets through the Decentralised Procedure. Clinigen provided strategic regulatory support, managed documentation and certification, and facilitated clinical and non-clinical interactions. The comprehensive management ensured timely approvals, allowing the client to focus on core activities while minimizing costs.
Read the case study to learn how Clinigen’s expertise in regulatory environments and end-to-end service offering were crucial in achieving successful market entry.
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