Global Regulatory requirements are very dynamic and becoming stringent with respect to the development, manufacturing, and distribution of biopharmaceutical products. Given the dynamic nature of regulations, medicinal products’ manufacturers are facing challenges in decoding and understanding the updated Regulatory compliance requirements, choosing the right Regulatory submission roadmap, and developing an appropriate Regulatory strategy to enter into the global markets.
The ideal way to overcome such Regulatory challenges is a comprehensive Regulatory intelligence support to define appropriate Regulatory strategy. Regulatory Intelligence mainly includes evaluating the Regulatory framework for targeted country/countries, identify the regulations and Health Authority (HA) guidance for the medicinal product approval process, registration dossier submission requirements, import licensing, and collate insights on practical challenges with the HAs during the application review and approval process.
With an overview of the targeted country, product classification, and registration requirements including the specific requirements for CMC, non-clinical, clinical, labeling, GMP requirements, and import regulations, a detailed Regulatory Intelligence (RI) report with Regulatory submissions roadmap will help manufacturers to arrive at a Regulatory strategy to commercialize the product in the country.
Freyr has a proven track record in supporting medicinal products manufacturers with the best Regulatory intelligence support and Regulatory submission strategies to commercialize medicinal products across the globe.
- Strategic support in identifying the optimal pathway for different types of applications in the global market (US, EU, Japan, Canada, Australia, and RoW).
- Identification of Regulatory compliance requirements and mitigation plans for the targeted countries.
- Intelligence on drug market-entry from one market to another.
- Intelligence for global clinical trial programs and large-scale product registration activities.
- Competitors landscape evaluation to prepare the right Regulatory strategy for product registrations.
- Product evaluation for suitability under expedited programs and Regulatory support for submission of expedited program requests (Fast Track designations, Breakthrough Therapy designations, Accelerated Approval process, and Priority Review designations).
- Expertise in dealing with developmental issues with various types of medicinal products (biologics, small molecules, medical devices, combination products, etc.).
- Developmental approach and Regulatory submission requirements for complex products.
- Identification of reference medicinal product as per the global commercialization plan and defining the right developmental approach and Regulatory submission roadmap.