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. To keep pace with and to sustain the market scenario, while simultaneously addressing health needs, Pharma, Biotech, Cosmetics, Medical Device, and Consumer Healthcare organizations should not only innovate new products in a compliant way, but should also ensure that they are accessible across the globe with stringent safety and efficacy measures taken. 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, Freyr offers a full spectrum of end-to-end Regulatory services that span across strategy to submissions and lifecycle maintenance.
- Global Market Analysis
- Regulatory Consultation
- Market Access and Regulatory Strategy
- Regulatory Intelligence
- Publishing and Submissions
- Regulatory Labeling
- Regulatory Artwork Services
- Regulatory Medical Writing
- Safety and Pharmacovigilance
- Audit and Validation
- Regulatory Software and Services
- Health Authority Interaction
- Product Registrations and Market Authorizations
- Lifecycle Management/Post Approval Activities
- Local on-the-ground Presence
- Regulatory Centralization