seQure Life Sciences is a niche services provider operating in the Life Sciences sector.
As the drug and device development process becomes more complex, time-consuming and costly, Sponsors need to rely on industry experts to advise on regulatory requirements, ensure quality systems are in place, and that pharmacovigilance practices are compliant and efficient.
seQure Life Sciences provides services and consultancy in four core areas:
Customers conducting both clinical and post-market trials can rely on quality pharmacovigilance services in these areas:
- Risk Management Plans
- Safety System Implementation & Hosting
- Case Processing & Reporting
- Literature Screening
- Signal Detection
- PhV Regulatory Consultancy in the EU or US
- EU QPPV Services
Pharmaceutical Companies are aware that regulatory requirements change constantly, and the consequences of not being compliant can be severe – from fines to delayed marketing authorization. seQure helps companies avoid these issue through sound regulatory advice, fully GVP compliant pharmacovigilance systems, set up and maintenance of Quality Management Systems, support with GxP audit, inspection preparation, and Computer System Validation.
Our expert team can also provide customized training courses in areas of pharmacovigilance and quality assurance for the GxP environment.