A fully integrated biopharmaceutical company was aiming to calculate the Health Based Exposure Limits (PDE/OEL reports) and required cleaning validation support to meet the GMP requirements. The client approached Freyr for medical writing services and had in-house database tools to meet the Regulatory compliance, Board Certified Toxicologists and European Registered Toxicologists (ERT). It was challenging to prepare and align the multiple report templates with the current Regulatory requirements, as there was limited data to access the safety.
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