Freyr has extensive capabilities to deliver Regulatory projects and Operational supporting engagements in flexible models that suit our clients’ needs and budgets. Many of our engagements are delivered with the right combination of Onsite and Offshore services. We constantly assess the risk / return parameters of key Regulatory functions that can be done Offshore.
Our Global Regulatory Affiliate teams work in conjunction with our Offshore-based Regulatory teams to offer significant value to our clients - the right combination of local support and cost-benefits of offshore-based services. Freyr’s offshore-based Regulatory experts also travel globally on several key engagements.
- Health Authority Interactions
- Product / Market specific Scientific Content Creation including Language Translations
- M1- Market specific legal and administrative documentation
Centralization / Support Activities
- Global Submissions Publishing
- M2-M5 Dossier Preparation
- CMC Change Control Management
- Artwork Management Regulatory Information (Data and Documents) Management
- Regulatory Intelligence
- Compliance Monitoring and Business Risk Management