• Phone: +44 (0)1476 570819
  • Email: bd@drugsafetysolutions.co.uk
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CONSULTANCY

Our business of product safety (pharmacovigilance, medical device vigilance, veterinary pharmacovigilance, cosmetovigilance) is based on mutual trust and respect between us and the client, and the patients they serve. As a matter of public health, our commitment to excellence in safety services is born out of a purpose to ensure medical products are safe and used correctly.

To this end, quality and compliance is the primary focus of our pharmacovigilance and product safety services. We understand that all companies are different, and are proud of our client centric company culture that allows a flexible approach that ensures we cater to your needs. We offer high quality, value added solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety such as clinical development, medical monitoring, medical information and regulatory services through our trusted partners.

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OUTSOURCING

We offer a full range of Pharmacovigilance and Product Safety services, including:

  • Provision of Qualified Person for Pharmacovigilance (QPPV) – local and EU
  • Set up and operation of PV System
  • Adverse Event processing
  • Literature surveillance
  • Signal detection and evaluation
  • Aggregate Reports (PSUR/DSUR)
  • Risk Management and Minimization
  • Pharmacovigilance audits and inspection readiness activities
  • Registration to EudraVigilance and registration of products in xEVMPD
  • Safety Data Exchange Agreements (SDEA) preparation/review and maintenance

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SUPPORT

Pharmacovigilance audits are an essential component of any pharmaceutical company’s Quality Management System. If carried out correctly, auditing provides an unbiased opinion of operational performance of the Pharmacovigilance system, measuring the system against its own procedures and against the regulatory guidelines, and ensuring that the system itself remains compliant with the regulations.

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TRAINING

Drug Safety Solutions organises and delivers a variety of training courses throughout the year. For further information on specific courses, to discuss a bespoke course or to book a place, then please contact Drug Safety Solutions by telephone on +44 (0)1476 570819 or email us at bd@drugsafetysolutions.co.uk.

CUSTOMER SAYS

DSSL’s knowledge is deep and varied, and the service is attentive and intuitive – they have a CAN-DO attitude.

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DSSL’s knowledge is deep and varied, and the service is attentive and intuitive – they have a CAN-DO attitude.

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DSSL’s knowledge is deep and varied, and the service is attentive and intuitive – they have a CAN-DO attitude.

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