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Compliance partner for adverse event reporting solutions across the drug life cycle.

Differentiators

1

Skilled people

Experienced team in handling multiple regulatories including US, EU, China & Middle East regions

2

Database Evaluation

Evaluation of world-wide available PV databases & supportive databases

3

Client Based Approach

Resource wise ready to cater for the ever expanding requirement/s of clients.

4

Case Processing

Team has experience in handling of Medico legal cases

5

Due Diligence

Technical assessment of Investment divestment deal

Strengths and Capabilities

  • Capability to ensure full fledged compliance with US, EU, Japan Health Authority regulations also for EEU, ASEAN, LATAM regions
  • Highly experienced Pharmacovigilance team with extensive experience in Pharma, CRO, KPO/BPO organizations
  • Experienced project managers to integrate client requirements and development of structured project manual and operating procedures
  • Subject matter experts including physicians with previous experience as QPPV (as applicable), PVOI (Pharmacovigilance officer in charge)
  • Robust QMS system
  • Validated Pharmacovigilance database and supporting tools
  • Well defined disaster recovery and business continuity plan Assurance of efficient TAT
  • Generation of project wise predefined key performance indicators (KPIs) and compliance metrics for reconciliation with the clients

Our Services

Holistic/Full Services

Pharmacovigilance (including medical device, vaccine vigilance & cosmetovigilance) services for major, mid and small size organizations are offered in varied models under holistic, customised and ad-hoc support categories.

End-to-end Pharmacovigilance services include:

  • Medical Information Contact Centre 
  • Scientific and Technical 
  • Quality Management systems (including SOP package)
  • Gap analysis 
  • Inspection/Audit support
  • LMS & Training
  • QPPV, PMSF support

Establishing Pharmacovigilance set-up and support till Go-Live

Specific Services

1. Medical Information Contact Centre

2. Scientific:

  • ICSR/Case processing (Clinical trial, post-marketing) for small molecules, biologics, devices, vaccines, cosmetic products
  • Literature Monitoring (Global/Regional)
  • Aggregate reports (PSUR/PBRER/PADER/DSUR/SBR/ACO/CES)
  • RMP/REMS
  • Signal detection and management

3. Clinical Trial vigilance:

  • Case processing for SAEs and reporting
  • Preparation of SUSAR reports, DSUR
  • Review of CT related documents including protocol, IB, CSR, SMP, MMP etc
  • Review of CT Line Listings
  • Preparation of Investigator Notifications

4. Technical

  • Quality Management (Development of SOP, Trackers, Templates & Forms)
  • Operations support
  • Project Management
  • Compliance Management: QMS, CAPA
  • Agreements (including total SDEA, Annexures with PV clauses)

5. Inspection & Audit Support

  • Inspection & Audit Support
  • Inspection readiness and support
  • Audit (Live/Remote)
  • Gap Analysis

6. Other Services

  • PV Physician/Scientist for Projects (Resourcing)
  • QPPV/Deputy QPPV/LPPV services
  • Eudravigilance registration and Maintenance
  • XEVMPD registration and maintenance

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