End to End Dossier Life-Cycle Management ​

Regulatory requirements in the life sciences industry are complex and constantly evolving, with different regions and health authorities having their own unique set of rules and procedures. This makes it challenging for companies to navigate the global regulatory landscape and ensure compliance with all the relevant requirements.

At RAC, we understand these challenges and have built our business around helping life sciences organizations meet their regulatory goals across the globe. Our team of experts has deep knowledge of the local pharma regulatory market space and can provide customized solutions spanning from strategy to submissions and lifecycle maintenance.

Whether you are seeking regulatory support for pharmaceuticals, generics, biosimilars, vaccines, cosmetics, OTC products, nutraceuticals/food and dietary supplements, or medical devices, we have the expertise to help you navigate the complex regulatory environment and achieve your goals.

Our full spectrum of regulatory services includes submission and management of registration dossier, post-approval changes, license renewal, variations dossier preparation and regulatory responses, transfers, site transfers, variations to the original variation, and more. We are committed to helping our clients achieve their regulatory objectives in a cost-effective and timely manner.

In addition to our expertise in regulatory affairs, we also offer a range of other services to support life sciences organizations, including clinical trial management, product sourcing, contract manufacturing, and scientific office creation. Our comprehensive suite of services enables us to provide end-to-end support to our clients, from product development to commercialization and beyond.

At RAC, we are committed to staying up-to-date with the latest regulatory developments and trends, and leveraging our knowledge and expertise to help our clients succeed in a rapidly evolving industry. Contact us today to learn more about how we can help you achieve your regulatory and business objectives.