Rajiv Rangan, Co-Founder & Co-CEOWith the vast and profound inclusion of science and its disciplines, companies that persevere to institute an application or product in the industry could be muddled by its regulations and the limitations they present. And since the life sciences industry’s delicate involvement with the elementals of life, the policies expected to be followed are quite stringent and cumbersome for some to adhere to on their own. Freyr, an end-to-end regulatory services provider, has been predominantly successful in mitigating the challenges companies face concerning compliance and supports players in the industry meet their business goals.
The complexities in the regulatory services were sparsely addressed in the industry, and the need to streamline services and solutions to manage them was on demand. Meanwhile, Freyr reviewed the regulatory-based services and how they evolved over a decade. It then decided to raise the curtains, offering an unmatched panorama of services and solutions in the sector. Regulatory affairs, market access, and regulatory intelligence are some of the company's services developed to equip each client with the latest trends in the market.
With more than 950 customers around the globe, Freyr has pioneered specialized Centers of Excellence (CoEs) exclusively by focusing on the entire regulatory value-chain backed by its rapidly growing workforce—its current strength is a little over 1250 employees. Most of these professionals are well-versed with many years of regulatory experience. In one particular instance, Freyr aided a USA-based leading generics drug manufacturing client and was looking for regulatory support in original abbreviated new drug applications (ANDAs), supplements, and periodic adverse drug experience report (PADER) submissions. The project presented challenges such as reviewing and filing high-quality submissions in stringent timelines. With an experienced resource pool, Freyr was able to provide end-to-end publishing support by reviewing the study documents, coordinating with the CRO, and making the final ESG submissions. With zero errors and over 70 percent cost benefits, the client was able to meet all the compliance and business requirements, respectively.
Today, companies require a business partner with global expertise and dedicated resources available across the globe to gain new market access, meet evolving Health Authority (HA) compliance needs, and reduce operational cost savings for new innovations. However, regulatory requirements vary globally—across every region, HA, and product category. For instance, if a US-based drug manufacturer is interested in marketing their product in the Middle East, the manufacturer may require a service provider who maintains knowledge of the region’s pharma regulatory market. The company is also expected to be able to customize a suite of regulatory services spanning various strategies for submissions, rather than a regular service provider who has expertise in only a single regulatory function.
Freyr’s decisive and assertive approach toward global end-to-end regulatory services is fairly unique considering its methodologies, classifications, formulations, and assessments. The company offers a full spectrum of regulatory services alongside lifecycle maintenance, which makes it easy to say that Freyr is a one-stop-shop to ensure a product’s global compliance.
