Services

Regulatory Affairs for Advanced Therapies

Regulatory strategy (EU, US, UK)
Scientific advice meetings & briefing packages
IND/IMPD/CTA submissions
Orphan drug designations, PRIME, RMAT, ATMP classificationst itemst item

Authoring support

Module 3 authoring (IMPD, MAA, IND, BLA)
Preparation for scientific advice meetings & briefing packages
Writing Module 3 summaries and strategy documents for life cycle maintenance

Project Management

Subcontracting network management
Vendor coordination
Outsourced regulatory operations

Custom Solutions

Flexible arrangements (ad-hoc consulting, interim support, long-term partnerships).