A Korean firm engaged in the manufacturing of wholesale pharmaceuticals approached Freyr for medical writing services. The client had to prepare the PDE reports and required cleaning validation support to meet the GMP requirements. As the reports were related to biosimilars and the availability of literature was very limited, it was challenging to prepare and align multiple reports with the current Regulatory requirements and deliver them within stringent timelines. However, Freyr overcame the challenges by following the most conservative approaches and provided high quality compliant reports.
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