Regulatory Affairs


We understand the importance of sound regulatory strategies in the ever evolving regulatory environment of clinical trials.  You need to know how updated guidelines will affect your clinical development programmes on a country, regional and global basis.  

Right first time - Regulatory strategy
It is essential to develop a regulatory strategy plan early in drug development to identify key challenges that may arise, and interact collaboratively with regulatory authorities. This will also enable you to ensure that plan aligns with the profile and commercialisation for the drug.

Support throughout the product lifecycle
Our team have the knowledge to support your needs throughout the product lifecycle. This includes defining the regulatory development strategy, producing clinical trial and marketing authorisation submissions, and providing post licensing support. ​

Full strategic and operational support in early drug development includes;

  • 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

​Clinical trial support services

  • Multinational and global submissions including biologicals, GMO, and vaccines
  • EU VHP support
  • Legal representative and local sponsor services
  • Skilled in acting as US agent for INDs and other agency interactions
  • New EU Clinical Trial Regulation No 536/2014 consultancy 
  • Preparation of investigator brochures
  • IMPD/IND and equivalents globally

Comprehensive regulatory intelligence system

Our regulatory intelligence combined with our operational expertise enables us to support your trial according to the latest agency developments.

Customised solutions according to your needs

Our regulatory professionals have broad therapeutic expertise and experience.  We also engage with an established network of international consultants.

The foocus is always on designing a package of services to meet your organisation and study requirements. Teams located in offices across the globe enable us to provide you with the right service, at the right time, according to your specific clinical development plan.  We pride ourselves in delivering a world class service to pre-agreed timeframes.

Experience you can trust

  • 150+ agency meetings completed, 20 orphan drug designation applications, and 140 expert reports/overviews
  • 150 ongoing clinical trials
  • 20 Full Voluntary Harmonisation Procedure (VHP) submissions