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Regulis Consulting Ltd

Tring, United Kingdom

Contact Details

First Floor, St Peter's House
Market Place
Tring
Hertfordshire
HP23 5AE

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Phone number: +44 144 289 0909
Fax number: +44 144 289 0903
Web address: http://www.regulis.com
Email address: enquiries@regulis.com

Company Profile

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.

Status: Independent Consultancy
Date established: 2001

Additional services

• 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)


Expertise

• 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


Awards, Membership and Accreditations

2013 – Shortlisted for the TOPRA Support Award
2012 – Winner of the TOPRA Horizon Award and shortlisted for the TOPRA Support and the Communication Awards
2011 – Winner of the TOPRA Support Award

Key Contacts

+44 (0)1442 891033
+44 (0)1442 891028
+44 (0)1442 891049
+44 (0)1442 891026
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