The Life Sciences market is growing and is expected to reach US$ 4,200 Million by the end of 2024. At the same time, the world is turning more protective about increasing health concerns. Alongside addressing the health needs and aligning with the market scenario, the pharma, biotech, cosmetic, medical devices and healthcare organizations shouldn’t only innovate new compliant products, but also ensure that they are accessible across the globe with stringent safety and efficacy measures. To enable products to reach the global market or to expand businesses to other regions/markets, what is required is a clear-cut map of product specifications along with the regional Regulatory requirements of targeted countries.
The Regulatory requirements vary at a global level, with every region, every Health Authority (HA) and every product category. Be it data requirements and integration, clinical trial phases and methodology, device classifications and Unique Device Identification (UDI) requirements, ingredient assessment and formulation reviews, data publishing and submission formats (either electronic or paper), every single procedure is unique and aligned with region-specific requirements. Given the intricacies of regional/local requirements, it is indeed a complex situation for manufacturers to ensure that they adopt the right path.
Adding to these global and regional procedural complexities, a handful of end-to-end Regulatory service providers make the situation even more critical for manufacturers seeking in-time global expansion in a cost-effective way. For example, if a US-based drug manufacturer is interested in marketing their product in the Middle East, they may require a service provider who has complete knowledge of the Middle East Pharma Regulatory market space along with some knowledge of a customizable suite of Regulatory services spanning across strategy to submissions, rather than a regular service provider who has expertise in only a single Regulatory function, and might incur huge costs for the drug manufacturer.
Enabling life sciences organizations to meet their Regulatory goals across the globe for Pharma, Generics, Biosimilars, Vaccines, Cosmetics, OTC, Nutraceuticals/Food and Dietary Supplements, and Medical Devices, RegSolutions offers a full spectrum of end-to-end Regulatory services that span across strategy to submissions and lifecycle maintenance.
Overview
Safety and Pharmacological
Health Authority Interaction
Product Registrations and Market Authorizations
Lifecycle Management/Post Approval Activities
Local on-the-ground Presence
Regulatory Centralization