Who We Are
As the drug and device development process becomes more complex, time-consuming and costly, Sponsors need to rely on industry experts to ensure quality systems are in place and that pharmacovigilance practices are compliant and efficient. PM Clinical focuses exclusively on pharmacovigilance services and quality assurance deliverables and consultancy with its team of industry leading experts.
Customers in the pharmaceutical, biotechnology and medical device fields can rely on quality pharmacovigilance services in these areas:
- Safety System Implementation & Hosting
- Case Processing & Reporting
- Periodic Reporting
- Literature Screening
- Signal Detection
- Risk Management Plans
- PhV Regulatory Consultancy in the EU or US
- EU QPPV Services
Sponsors are aware that regulatory requirements change constantly, and the consequences of not being compliant can be severe – from fines to delayed marketing authorization. PM Clinical helps companies set up and maintain an efficient Quality Management System (QMS) and supports with GxP audit and inspection preparation.
Our expert team can also provide customized training courses in areas of pharmacovigilance and quality assurance for the GxP environment.