Regulatory Submission Roadmaps/Regulatory Intelligence Services – An Overview
Regulatory requirements are dynamic and stringent in the development, manufacturing, and distribution of biopharmaceutical products. Given the nature of global regulations, medicinal products manufacturers face challenges in understanding the updated Regulatory compliance requirements, choosing the right Regulatory submission roadmap, and developing an appropriate Regulatory strategy to enter the global markets.
The ideal way to overcome such Regulatory challenges is comprehensive Regulatory intelligence (RI) support to define appropriate Regulatory strategy. Regulatory Intelligence is evaluating the Regulatory framework for targeted country/countries, identifying the regulations and Health Authority (HA) guidance for the medicinal product approval process, registration-dossier submission requirements, import licensing, and collating insights on practical challenges with the HAs during the application review and approval processes.
With an overview of the targeted country, product classification, and registration requirements, including the specific requirements for CMC, nonclinical, clinical, labeling, GMP requirements, and import regulations, a detailed Regulatory Intelligence report with a submission roadmap will help manufacturers 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 and Regulatory submission strategies to commercialize medicinal products, globally.
Regulatory Submission Roadmaps/Regulatory Intelligence Services - Freyr Expertise
- Strategic support in identifying the optimal pathway for different applications in the global market (US, EU, Japan, Canada, Australia, and RoW).
- Innovative Licensing and Access Pathway (ILAP) consulting for the UK.
- Identification of Regulatory requirements and mitigation plans for the targeted countries.
- Intelligence on medicinal product’s market entry.
- Intelligence on 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 submitting expedited program requests (Fast Track designations, Breakthrough Therapy designations, Accelerated Approval process, and Priority Review designations).
- Expertise in developmental issues with various medicinal products (biologics, small molecules, medical devices, combination products, etc.).
- Developmental approach and Regulatory submission requirements for complex products.
- Identification of Reference Medicinal Products (RMPs) per the global commercialization plan and defining the right developmental approach and Regulatory submission roadmap.