Client Overview
The client is an Italy based multinational pharmaceutical company specializing in innovator products. Seeking to expand its footprint, the organization aimed to commercialize an innovative product for arthritis and muscular dystrophy in the EU and the USA.
Client Background
While scientifically strong, the client had internal gaps in understanding US FDA and EMA expectations, particularly for IND oversight and pre NDA/MAA requirements. Critical activities, such as facility establishment registration and drug naming conventions, lacked clear regulatory ownership.
Services in Scope
Regulatory gap analysis and strategy for US and EU submissions.
Health authority interactions for both FDA and EMA.
Publishing and submission support for NDA, MAA, IND, and DMF packages.
IND lifecycle maintenance, including SUSAR notifications and DSUR submissions.
Facility establishment registration support and guidance on naming conventions and related pre submission requirements.
Challenges
Limited in house regulatory expertise on FDA/EMA requirements for innovator products.
Lack of oversight for IND activities related to oral suspension formulation.
Insufficient understanding of pre NDA/MAA expectations, including facility registration and naming.
Solution
Freyr built an integrated US–EU Regulatory strategy covering development, registration, and maintenance. A combination of gap analysis, detailed submission planning, and hands on module preparation ensured that both NDA and MAA pathways were aligned, efficient, and compliant.
1
Performed gap analysis across development and documentation to map deficiencies against FDA and EMA requirements.
2
Supported and guided health authority interactions, offering strategic advice on drug development, trial oversight, and submission expectations.
3
Prepared modules for NDA and MAA submissions, leveraging content reuse to minimize authoring effort while preserving compliance.
4
Maintained IND activities, including SUSAR and DSUR submissions, and assisted with facility establishment registration and related pre submission requirements.
Impact
- Accelerated health authority interactions enabled timely submission and approvals.
- Reduced submission effort by reusing NDA content for MAA where appropriate.
- Ensured IND monitoring and submissions aligned with the latest HA expectations, minimizing compliance risk.
The engagement helped the client manage dual-region regulatory complexity with a unified, efficient strategy for its innovator product. By providing strategic guidance and meticulous submission and IND support, Freyr enabled smooth entry into EU and US markets. The client now has a repeatable regulatory framework for future launches.
