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.

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Clinical Safety

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

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Global Literature Search & Management

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

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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.

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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.

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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.

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