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Clinical Trial – Global Regulatory Affairs

Advisory services keeping your clinical trial aligned with regulatory developments

You need to know how updated guidelines will affect your clinical development programmes.

Our Clinical Trial – Global Regulatory Affairs (ctGRA) teams will work with you to develop a regulatory strategy early in development to identify key challenges that may arise and to interact collaboratively with regulatory authorities. This will ensure that your plan is aligned with the product profile and commercialisation requirements.

Keep updated with the latest regulatory changes by subscribing to our monthly Global Regulatory Intelligence newsletter. All you need to know, directly to your inbox.

  • 673

    Ongoing clinical trials*

  • 224

    Clients supported*

  • 20

    Orphan drug applications

Clinical trial support services

Our extensive regulatory intelligence combined with our operational expertise ensures that your clinical trial is aligned with the latest regulatory agency developments. Our services include:

  • Multi-national and global submissions (CTA/IND and global equivalents)
  • GMO, IVD and Medical Device submissions associated with IMPs 
  • Legal representative and local sponsor services
  • US agent support for INDs and other agency interactions
  • EU Clinical Trial Regulation No 536/2014 consultancy 
  • Preparation of investigator brochures

In addition, we provide full strategic and operational regulatory support, including:

  • Global regulatory intelligence
  • Orphan drug applications
  • Paediatric investigational plans
  • Scientific advice and FDA meetings
  • Due diligence for marketing authorisation acquisitions and gap analysis
  • Risk management and mitigation strategy
  • Cross-functional project plans including budget and schedule management 
  • IMPD authoring

*in the last 12 months (2023/24)

ema-guideline-regulatory

EMA guideline on computerised systems and electronic data in clinical trials

This whitepaper provides an overview of the evolution of the new EMA guideline on computerised systems and electronic data, its scope, and its impact.

Read the whitepaper
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