Pharmacovigilance Services

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Pharmacovigilance Services

Complete Case Management

ADR Case Processing, Reporting & Submissions 24/7/365: Drugs, Vaccines, Medical Device, Cosmetics & Nutritionals

  • Book in, Triaging & 24/7/365 Case Management Support.
  • Data entry into validated electronic PV database.
  • 100% Quality control of all ICSR including medical QC.
  • Medical review and assessment, narrative writing, MedDRA coding.
  • Product Quality Complaints Management.
  • Reporting & Submissions: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.) to worldwide regulatory authorities.

Literature Review, Search & Monitoring

Safety Data Exchange Agreement Management

  • Authoring and preparation of SDEAs customized per global regulatory requirements.
  • Review of SDEAs.
  • Negotiating safety aspects to be included in the SDEAs with business partners.
  • In-house Web based Safety Data Exchange platform, “STREAM”.

Provision and Support with EQ-QPPV and DQPPV

  • 24/7/365 Support with EU QPPV & DQPPV Good PV Practice Modules (GVP) –
    New EU PV Regulations.
  • Oversight of the PV System in terms of structure & performance to ensure appropriate collation of ADRs, preparation and sign off of regulatory documents (PSURs etc) and Post-Authorisation Safety Studies (PASS Studies).
  • Ensuring all requests from Regulatory Authorities are answered completely and promptly.

Signal Detection – Benefit Risk Evaluation

  • Support with Identification and Prioritization of Signals from company databases.
  • Complete work up of signals including, signal evaluation, epidemiological input and closing of signals.
  • Authoring of Signal Evaluation Reports (SERs) or Issue Work Ups of signal for regulatory submission.
  • Communication of Signals to Regulatory Authorities and Prescribers.

Clinical Safety Management Services

  • MedDRA Coding and Data Analysis
  • Reconciliation of Clinical & Safety Databases
  • Migration of Data and Legacy data from various databases
  • Generation of CIOMS Line Listings
  • Data Mining from various databases

Drug Safety/Pharmacovigilance Services for different phases

  • Safety Support for Different Phases
  • Preparation of Medical Management Plan
  • Preparation of Safety Management Plan
  • Preparation of Safety sections of eCTD for NDA, IND & BLA submissions
  • NDA, IND and BLA Safety Review
  • Compassionate Use Programs Support & Monitoring