Aggregate Safety Report Authoring

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

Our team is fully trained for handling the review of cumulative safety data from a wide range of sources, on a periodic basis, and submitting the findings to worldwide RAs.

Aggregate Safety Report Authoring Services

  • Expertise in preparation of pharmacovigilance documents at defined time points (pre- or post-authorization phase) such as:

    • PSURs
    • PBRERs
    • ASRs
    • DSURs
    • AdCOs
  • Timely submissions to the competent authorities

Other Drug Safety Services

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.

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.

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.