BioKinetic has an excellent working relationship with the local regional ethics committees and the UK competent authority, MHRA.
Our internal regulatory team will walk through the approval process with you for a ‘right first time’ submission. Within the favourable UK regulatory environment, there is a:
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. BioKinetic is a holder of controlled drugs licences for schedule II-IV drugs.
Feasibility & Study Award
Database lock, review of CSR, study close-out