Pharmacovigilance and Drug Safety Services

PharmaVigilance team develops and implements customised strategies for PV and Drug safety services. PV and all drug safety issues are relevant to every person whose life is touched in any way by medical interventions. Our team comprises of expert professionals who are experienced and skilled to ensure your accomplishment with high standards of our services. We maintain the quality and support in improving your probability of success. We have experience in writing PV related documentation such as RMPs, PSMFs and critical SOPs to support MAAs in the EU.
As a company we believe in the power of collaboration, and through integrated partnerships with our collaborators, we offer clients the best possible solutions for their needs.

Auditing Services

Due to the stringent regulations and increasing demands from Regulatory Authorities, the pharmaceutical companies must ensure that a robust PV system is in place which is being monitored and improved continuously in order to provide patient safety. We can help you to achieve this to high standards with our following services:

  • Conducting Audits: Our audit activity includes conducting audits of pre and post marketing PV systems and documentation, affiliates, distributors, marketing partners and service providers, QPPV Office, process audits such as patient support programmes and aggregate report writing processes, etc.
  • Conducting Gap Analysis: We conduct gap analyses and identify gaps in PV systems by assessing against the regulatory requirements. We offer expert advice and solutions to rectify any deficiencies observed during these analyses.
  • Preparing Checklists for Audits: We provide checklists to support and guide the auditors during the audit process. This is also included in our training program for conducting PV audits.
  • CAPA Management: We provide post-audit and post-inspection support for CAPA management. We provide expert advice on performing root cause analyses and determining a suitable CAPA plan to address the findings. This is then followed up with the implementation of the CAPAs within the timelines agreed with the Regulatory Authorities.