Regulis Consulting Ltd
Regulis, founded in 2001, is an independent consultancy committed to providing cost effective global drug safety and PV expertise and excellence. Utilising its team of experts and a global professional network, Regulis delivers customer focussed and compliant solutions, in what is a rapidly evolving and demanding regulatory environment. Regulis provide and manage partial and full PV services for mAHs, including the provision of the EU QPPV (with medical support) and a global safety database. the team has experience of working with both start-up companies and top 20 pharmas and has guided its clients through a number of authority inspections. In addition to post-marketing PV, Regulis also provide and manage drug safety services for sponsors throughout all phases of product development. Its breadth of experience extends from single-centre clinical trials to multi-centre global clinical trials.
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• Broad experience of clinical trial drug safety and post-marketing PV
• Team of 15+ drug safety and PV specialist consultants
• Experienced EU QPPVs and PV physicians
• mHRA inspection experience
• Service provision to start-up and big pharmas (including top 20 pharma)
• PSmF, PSUR, dSUR, RmP, SdEA
• Interventional studies, non-interventional studies, market experience
• mAH/Sponsor registration with Eudravigilance
• Product registration with the XEVmPd
• Provision of the EU QPPV (and medical support)
• Provision of LPPVs/nRPs
• Provision of the global safety database
• Creation and maintenance of the PSmF
• Preparation and submission of periodic reports(i.e. PSUR, dSUR/ASR)
• Routine literature review
• Signal detection and validation
• AdR processing from market experience
• SAE processing from interventional studies/clinical trials
• ICSR/SUSAR expedited reporting to nCAsand Eudravigilance
• Preparation of customised SdEAs/PV agreements
• Preparation of customised PV SoPs
• Preparation of RmPs (and assistance with mAA)
• Handling data from non-interventional studies (and named-patient/compassionate use programmes)
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