Quality, Regulatory, Clinical

What We Do

Regulatory affairs

Support for Early Phase Clinical Development Programmes:

Product development consultancy:

  • Fielding of ad hoc queries and questions
  • Regulatory due diligence

Preparation and review of technical documents, including:

  • Agency meetings (briefing documents, minutes)
  • Orphan drug designation applications (EU and US)
  • CTA applications

EU Legal Representative services:

  • In support of non-EU Sponsors of clinical trials in the EU (through QRC Ireland)

SME services:

  • In support of non-EU small and medium sized companies (through QRC Ireland)

Bespoke training in regulatory procedures:

  • Bespoke training in regulatory procedures