Home » Regulatory

Regulatory

Our clients must operate within a tight, complex and ever-changing framework of regulation. As a result, Illingworth Research is skilled in assisting companies to adopt effective and appropriate regulatory strategies for both investigational products and medical devices.

As with all our services, our approach is flexible and designed to meet the individual needs of our clients and can include:

  • Regulatory strategy development
  • Clinical, non-clinical and CMC expertise
  • Preparation and submission of CTAs/INDs for phases I-IV
  • Regulatory agency liaison including meeting preparation and facilitation
  • Marketing authorisation applications
  • Ethics committee submissions

In many cases, it can be faster to obtain regulatory approvals for studies in the UK. We have an extensive network of contacts within the UK industry and can put you in touch with the right people for your business. We can help you understand market access, clinical study requirements and study planning both in the UK and Europe.