Drug Safety Solutions Ltd
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| Drug Safety Solutions Ltd | |
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| Type | Public / Private |
| Founded | 2002 |
Drug Safety Solutions Limited was founded in 2002 by the Director Carol Markwell.
Carol has extensive knowledge and experience of all aspects of pharmacovigilance, both in industry and as a consultant. Since 1979, Carol has worked in Medical Information and publishing before spending more than 15 years in global pharmacovigilance roles within international pharmaceutical companies. She completed a Post-Graduate Diploma in Pharmacovigilance (University of Hertfordshire) in 1997. As a principal consultant her experience was brought to bear by acting as QPPV in the EEA.
At Drug Safety Solutions Limited, she is supported by an experienced team of pharmacovigilance and medical professionals who are committed to providing a friendly, efficient service in all areas of pharmacovigilance. All DSSL team members have years of experience in the pharmaceutical industry and up to 20 years experience in pharmacovigilance. Drug Safety Solutions Limited (DSSL) offers an independent pharmacovigilance consultancy and support service, including advice, guidance and support to pharmaceutical companies, process reviews, audits and mock inspections, training and inspection preparation, in short everything you need to be compliant
The need for effective and compliant pharmacovigilance has never been greater. Regulatory requirements for pharmacovigilance change constantly, becoming more complex year on year: Are you compliant with electronic reporting, the Article 57 database (xEVMPD) submissions, risk management plans, signal tracking[1]
Drug Safety Solutions Limited clients comprise medium and small innovative companies, generic pharmaceutical companies and commercial sponsors, providing services such as:
- Outsourcing of data entry (partial or complete) into clients’ own or the DSSL safety database – PV Works
- Expedited reporting including electronic submissions via Eudravigilance
- Consultancy
- Assistance with Risk Management Plans, PBRERS / PSURs, PSMF, SOPs and other pharmacovigilance documents.
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