Regulatory Affairs Services

To ensure timely and accurate compliance with regulatory requirements by compiling, evaluating, and submitting the annual report to the USFDA, adhering to all relevant guidelines

The client, an Italy-based pharmaceutical company needed help expanding their innovator product into the EU and USA markets but lacked in-house Regulatory expertise. They turned to Freyr, who provided strategic guidance and end-to-end services, including submission support. Freyr's comprehensive assistance led to successful Regulatory proceedings, timely approvals, and enhanced compliance for their product in both markets.

An Italy-based pharmaceutical company had faced Regulatory challenges with the FDA for its complex generic injectable product and required comprehensive support to meet FDA requirements. They had turned to Freyr, who offered end-to-end assistance, including submission guidance and CFR-based recommendations. Freyr's support transformed the company's Regulatory strategy, ensured compliance, and streamlined the approval process.

A leading US pharmaceutical company had faced significant challenges in managing over 15 new and approved products (ANDAs/NDAs) due to a lack of in-house Regulatory expertise and limited FDA knowledge. Seeking comprehensive Regulatory support, they had turned to Freyr. Freyr's expert team provided strategic guidance, submission support, and ongoing Regulatory operations management, offering end-to-end Regulatory solutions that ensured seamless submission processes and continuous Regulatory compliance. As a result of Freyr's support, the pharmaceutical company achieved zero rejections and maintained Regulatory excellence.

The client, a major Italian pharmaceutical company, had faced stringent US FDA expectations for their enzyme replacement therapy products and struggled due to a lack of in-house BLA expertise and complex Regulatory challenges. Seeking comprehensive support, they had turned to Freyr. Freyr had provided strategic Regulatory submissions and expert guidance, ensuring seamless approvals. This empowered the client to manage future Regulatory issues independently, achieving Regulatory success and self-sufficiency.

A US-based pharmaceutical company had faced high attrition rates and limited in-house expertise, struggling with the Regulatory operations of 70+ ANDAs/NDAs. They had turned to Freyr for comprehensive Regulatory services. Freyr had provided strategic guidance and submission management, transforming the company's Regulatory operations. This support ensured seamless operations, timely approvals, and enhanced compliance.