PV Quality & Compliance Management

Sitero ensures quality-driven PV services which are curated to the needs of our clients envisaging the compliance to the current global regulations.

Our stringent quality assurance measures help us to meet Key Performance Indicators resulting in satisfactory performance.

PV Quality & Compliance Management Services

  • Conducting PV audits
  • Ensuring suitably skilled and adequately trained staff assigned for respective activities
  • Setting-up Key Performance Indicators
  • Placing adequate effective checks and balances in place
  • Periodic Quality & Compliance metrics generation
  • Thorough analysis of the data & root cause analysis of any non-conformances
  • Preparation of Quality improvement plans
  • Mock audits and preparatory sessions

Other Drug Safety Services

E2E Case Processing

We provide end to end (E2E) Pharmacovigilance and Clinical Safety services to Pharmaceutical, Biotechnology and Medical Device companies.

Clinical Safety

We understand the criticality of maintaining Investigational Medicinal Product & Patient information in clinical trials.

Global Literature Search & Management

Sitero offers medical literature monitoring services by well trained and highly experienced literature experts.

Aggregate Safety Report Authoring

Sitero offers comprehensive, concise and critical analysis of the risk-benefit balance of the medicinal products.

EU & UK QPPV and/or Responsible Person (RP) Services

To be compliant with GVP Module-I, Sitero can offer to its customers EU & UK QPPV & RP services by duly experienced and qualified personnel with 24X7 availability to comply with EU & MHRA regulations.

Safety Evaluation & Risk Management

Our medically qualified team with hands-on experience on signal management and risk minimization activities provides strategic medical support across various therapeutic areas.

Safety Data Exchange Agreements (SDEAs) / Pharmacovigilance Agreements (PVAs)

Our skillfully trained team members are responsible for handling the preparation of SDEAs and ensuring the compliance.

Additional Services

Sitero provides wider range of other support services. We provide best-in-class one-stop solutions to our clients: regulatory intelligence, pharmacovigilance master file (PSMF) Creation & Maintenance, XEVMPD / Article 57 Database Maintenance and PV SOPs Authoring & Maintenance Support.