Pharmacovigilance

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Pharmacovigilance

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

Differentiators

Skilled people

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

Database Evaluation

Evaluation of world-wide available PV databases & supportive databases

Client Based Approach

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

Case Processing

Team has experience in handling of Medico legal cases

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

ADVITY RESEARCH PRIVATE LIMITED