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Regulatory affairs - clinical support
Advisory services keep your you clinical trial aligned with regulatory developments
You need to know how updated guidelines will affect your clinical development programmes
Our regulatory 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.
Experience you can trust
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150
Ongoing clinical trials -
140
Expert reports/overviews -
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:
- Multinational and global submissions (IMPD/CTA/IND and global equivalents)
- EU Voluntary Harmonisation Procedure (VHP) support
- Legal representative and local sponsor services
- US agent support for INDs and other agency interactions
- New 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

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.
In this section
- Decentralised Clinical Trial Solutions
- Real World Intelligence
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Cardiac Safety Monitoring
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Clinical & Scientific Operations
- Biostatistics
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Case studies
- Clinical Operations
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Clinical Supplies Management
- COVID-19
- Clinical data science
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Endpoint Adjudication Services
- Global Logistics
- Interactive Response Technology
- Investigator Payments
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Medical Affairs
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Medical Call Centre Services
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Medical Writing & Publishing
- Pharmacovigilance
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Project and Program Management
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Site Identification and Feasibility
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Consulting
- Early Clinical
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Laboratories
- Language Services
- Medical Imaging
- Site & Patient Solutions
- Strategic Solutions
- Symphony Health
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Technologies
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Decentralised Clinical Trial Solutions