BioKinetic has an excellent working relationship with the local RECs and the UK Competent Authority, the MHRA. Our Internal Regulatory team will walk through the process with you for a ‘right first time’ submission. Within the favourable UK regulatory environment:
• Guaranteed 14-day turnaround for Phase I CTA
• Guaranteed 21-day turnaround for Phase I REC/IRB
In addition to ICH GCP compliance, BioKinetic Europe operates within the UK (MHRA) and
EU (EMEA) regulatory frameworks. We have successfully completed both MHRA GCP and
GMP inspections and are holders of a current Manufacturing Authorisation for IMP, which
includes vaccines.
Useful Links:
National Research Ethics Service (NRES)
Medicines and Healthcare products Regulatory Agency (MHRA)
European Medicines Agency(EMA)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Regulatory Metrics
•    100% of our studies are submitted within REC timeframes
• REC/IRB submissions receive verbal legally binding opinion on meeting date so voluntee screening can begin. A signed REC letter of opinion is sent via email to expedite study start.
• Phase 1 CTAs submitted by BioKinetic receive competent authority (CA) opinion within 14 days. UK CA are committed to achieving this.
• REC submissions – a  seven day turnaround from final protocol to submission with our internal regulatory experts.
• 99% of our studies have started full.
• A strong collaborative relationship with LREC and UK CA.