Regulatory & market support

Supporting long-term success beyond approval.

Key Services

We manage post-approval studies, real-world evidence, and market strategies to sustain product value.

Post-market studies and surveillance registries
Post-market studies and surveillance registries
Post-market studies and surveillance registries
Integration of RWE into regulatory and HTA submissions
Integration of RWE into regulatory and HTA submissions
Integration of RWE into regulatory and HTA submissions
Long-term safety monitoring and medical science liaison (MSL) support
Long-term safety monitoring and medical science liaison (MSL) support
Long-term safety monitoring and medical science liaison (MSL) support

Our Approach

  • Develop registry protocols and ensure U.S./EU post-market compliance

  • Create RWE-based strategies and HTA dossiers aligned with payer expectations

  • Monitor safety signals, incorporate PROs and QoL data, and meet reporting standards

  • Facilitate advisory boards and deliver scientific communications