Pharmacovigilance Services

Pharmacovigilance Services
Product Description

Azidus provides pharmacovigilance services such as: Assessment of serious adverse event (SAE) and reporting during clinical trials, submission of reporting forms 3500A, Blue card, Yellow card, CIOMS I to respective drug regulatory agencies within timelines, adverse drug reaction (ADR) assessment and reporting to drug regulatory agencies during clinical trials and post marketing phase, preparation and submission of individual case safety reports (ICSR), preparation and review of periodic safety update report (PSUR), preparation and submission of annual safety reports (ASR) / development safety update reports (DSUR), risk management assessments and plans, safety case narratives, causality assessment (WHO scale, Naranjo's scale assessment etc.,), signal detection and evaluation, conduction of pharmacoepidemiological studies, experienced and dedicated pharmacovigilance professionals to handle the projects.

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AZIDUS LABORATORIES LIMITED

  • IN
  • 2015
    On CPHI since
View company profile

AZIDUS LABORATORIES LIMITED

  • IN
  • 2015
    On CPHI since
View company profile

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AZIDUS LABORATORIES LIMITED resources (1)

  • BA/BE Capabilities

    Brochure BA/BE Capabilities

    AZIDUS is a full service clinical research organization catering to the technical needs of pharmaceutical and biotechnology industries for the conduct of BA/BE studies, Clinical trials, Clinical Data Management, Pharmacovigilance and Regulatory submission to the Global drug regulatory agencies.