The client, a US-based leading hair dye company, approached Freyr to support them in assessing the label of one of their products as per the Japanese Cosmetic regulations. Freyr performed a comprehensive label assessment of the product as per the Japan cosmetic labeling regulations and suggested the required changes with respect to the claim and warnings, which must be declared on the label.

Download the proven case to find out how Freyr managed to perform label assessment for cosmetics as per the Japanese regulations.

An India-based API’s manufacturing company wanted 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 required database tools to meet the Regulatory compliance, Board Certified Toxicologists (DABT) and European Certified 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.

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.  

A leading consumer goods company approached Freyr for assistance in preparation of the cosmetic safety assessment reports and provide PIF submission support. Though the client had in-house Regulatory software tools to provide updated Regulatory updates, Board Certified Toxicologists (DABT) and European Registered Toxicologists (ERT), it was challenging to prepare the report templates as per the Regulatory requirements. Moreover, there was limited data to assess the safety and multiple ingredient products had to be delivered with less turnaround time.

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.

The Client, based in Netherlands, is a Leading inventor of Smart AI program for mammography and breast imaging. The client approached Freyr to avail Regulatory services for product registration and Authorized Representative (AR) support in Malaysia. Freyr performed thorough assessment of products as per the Medical Device Authority (MDA) requirements and provided Strategic Regulatory approach for registration of the devices in scope.

Download the case study to decipher how Freyr performed product registration and Authorized Representative (AR) services in Malaysia.

A South Korea-based global manufacturer of biomedical devices, surgical devices and medical implants in the field of Aesthetics was aiming to expand their products in the ASEAN region. As the client was new to the target market, they approached Freyr for device classification, registration and local representation services. It was challenging for the client to navigate the ASEAN markets, as they had unique Regulatory requirements, the devices in scope were of high-risk and the detailed technical dossiers were to be submitted in both Thai and English.