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Clinical Trial Global Regulatory

Advisory and operational services keeping your clinical trial aligned with regulatory developments

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

Our Clinical Trials Global Regulatory team provides specialist consulting and operational services to ensure that Regulatory Agency (RAs) and Central Ethics Committees/IRBs clinical trial authorisations are in place and compliant with the complex web of requirements. Our team works with clients to create a submission strategy early on, identify key challenges that may arise and mitigations to ensure successful assessment outcomes. 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

*in the last 12 months (2023/24)

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:

  • Country-level clinical trial submissions and approvals (CTAs), including RAs and CECs/CIRBs
  • Clinical trial authorisation (CTA) development, submission, approval, and life cycle management
  • IP labelling text development and country adaptation
  • IMPD and quality/technical regulatory document development and maintenance
  • Redaction of clinical trial materials
  • RA and CEC meetings related to the clinical trial authorisations
  • Service-related strategic consulting, including submission and timelines strategy
  • Functional service delivery for any of the above services

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

  • Regulatory and country intelligence
  • Orphan drug applications
  • Pediatric 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
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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