Regulatory Operations

A European multinational pharmaceutical company needed to ensure Regulatory compliance and efficiency across the US and RoW regions for their numerous antibiotic products. They had turned to Freyr for comprehensive end-to-end labeling support. Freyr had created and reviewed ANDA labeling components, delivering compliant, submission-ready documents. This streamlined partnership resulted in 100% right-first-time submissions and eliminated "Refuse to File" instances.

A leading biopharmaceutical company faced the challenge of ensuring Regulatory compliance and enhancing the readability of various labeling documents across multiple regions. They had turned to Freyr for comprehensive text review and formatting support. Freyr meticulously supported the client, resulting in high-quality, submission-ready documents that ensured Regulatory compliance.

A leading US-based pharmaceutical manufacturer had faced challenges in updating over 1500 artworks to meet Regulatory standards during site transfer and name change activities. They had turned to Freyr for comprehensive end-to-end labeling support. Freyr ensured a seamless labeling transition, resulting in zero Refuse to File instances and quick turnaround times.

A USA-based generic pharma company, dealing with complex molecules across multiple therapeutic areas, had faced Regulatory challenges with an active product portfolio. They had turned to Freyr for comprehensive end-to-end labeling support. Freyr ensured Regulatory compliance and efficiently managed queries, significantly enhancing the company's Regulatory compliance and operational efficiency.

A leading Canada-based generic manufacturer needed comprehensive support to comply with Health Canada's new guidelines across multiple therapeutic areas. Facing organizational challenges and outdated templates, they had turned to Freyr for assistance in updating and creating compliant labeling documents. Freyr provided support that integrated the latest requirements, resulting in fast, efficient, and accurate labeling updates.

A prominent US-based multinational biopharmaceutical company needed artwork support in diverse languages for biologics and new molecular entities in various therapeutic areas. They had collaborated with Freyr, who provided comprehensive artwork services supporting operations across North America, Europe, APAC, and other regions. Freyr ensured 100% quality for client satisfaction and maintained 100% TAT for timely delivery, fostering client trust.

The client, a US-based pharmaceutical manufacturer, had needed to update over 1500 injectable product artworks within a stringent two-month deadline, amidst an Adobe update and other Regulatory challenges. They turned to Freyr for comprehensive support. Freyr had meticulously overcome technical challenges and ensured compliance, delivering seamless and error-free artwork updates on time with 100% quality.

A Danish specialty pharmaceutical company needed quality, compliance, and efficiency in artwork operations across 35 countries. Faced with multiple submissions and the need for artwork operations support, they had turned to Freyr. Freyr had delivered end-to-end services, ensured 100% quality, and streamlined project execution. This comprehensive support met the client's diverse needs, ensuring Regulatory compliance and operational efficiency.

A leading Canada-based pharmaceutical company had sought to transition to a consolidated outsourcing model to support artwork transitions for generic products across Canada, Mexico, Australia, and India. They had turned to Freyr for comprehensive end-to-end services. Freyr's support facilitated a seamless transition, resulting in zero artwork recalls and over USD 300K in cost savings within seven months.

An American multinational pharmaceutical company had engaged Freyr to facilitate a swift MAH transfer process following its acquisition of an Indian company. Faced with the challenge of updating over 1000 artworks across 40+ countries within a tight timeframe, the company had turned to Freyr for end-to-end support. Freyr's comprehensive approach ensured 100% quality and timely delivery.

The client, a Japanese pharmaceutical and biotechnology company, had sought to accelerate global submissions and ensure compliance. Leveraging a decade-long partnership, they had turned to Freyr for comprehensive support. Freyr provided submission planning, eCTD publishing, and submission services while expanding global resources across multiple countries. This support resulted in faster market entry and improved operational efficiency.

The client, a Japanese drug manufacturer, had faced challenges entering the US market and needed to streamline and standardize their submission processes. They had turned to Freyr, who standardized procedures and facilitated a seamless transition from the existing vendor. Freyr's expertise resulted in faster approval cycles, strict compliance with US regulations, and enhanced operational efficiency, enabling the company to successfully enter the US market.

A Japanese midsize global pharma and biotech company, having collaborated with Freyr for over three years, had sought Freyr's expertise for comprehensive submission publishing support in the US and Canada. Freyr had defined, implemented, and maintained best practices in publishing processes, ensuring 100% on-time submissions and achieving over 50% cost savings. This significantly boosted the company's process efficiency and compliance.

A US-based multinational company had faced multiple Regulatory challenges with eCTD submission compliance in the EAEU region. They had turned to Freyr for comprehensive consultation support. Freyr's meticulous approach resolved their compliance concerns, resulting in rapid turnaround times, zero errors, and enhanced Regulatory efficiency.

A global healthcare company required comprehensive Regulatory support for managing over 40+ submission operations for their gynecological products in China and Japan. They had turned to Freyr, who provided end-to-end submission services. Freyr efficiently managed the high volume of submissions, enhanced the company's operational efficiency, and ensured Regulatory compliance.