Are you worried or confused about the new regulatory environment planned for the UK?

The new regulatory environment planned for the UK does not need to cause either confusion or worries for drug developers. Through our extensive experience of MHRA procedures, we can help provide you and your team with all the necessary support whether you are looking for a smooth transition or if you are completely new to the UK.

Our services and our expertise cover:

  • Strategic advice and support for all UK submissions and procedures
  • Regulatory submissions including: MAA, PIP, ODD, CTA, Life-cycle management, Project Orbis and Access Consortium Procedures
  • PV Services including: PSMF, audits, RMP, SOP writing, PSUR/PBRER, national contact person for pharmacovigilance
  • eCTD publishing and submission through MHRA’s Submissions Portal
  • Medical Devices including technical dossier preparation

Contact us now to hear how our UK team can support you and your plan.

Help

We believe that MHRA has ambitious plans to streamline access of new and existing medicines to patients in the UK to help make the period of implementation after January 1st 2021 a period of opportunity.

So let us help you make the most of that!

MHRA’s post-transition period guidance

Our Experts

Dr Thomas Lönngren

Strategic Advisor

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Dr Brian Edwards

Principal Consultant

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Dr Roz Cox

Principal Consultant

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