Pharmacovigilance Services

Product Description

In addition to our PV physicians, medics, and medical writing team, we offer a full range of customized PV services that are fully compliant and high in quality.

In order to maximize product potential and ensure patient safety, we help our clients ensure regulatory compliance and manage the risk-benefit profile of their products.

We provide various services and solutions tailored to each client's needs, from outsourcing individual activities to setting up and managing a global PV system.

KEY Pharmacovigilance Services:
Eudra Vigilance

Signal Detection and Evaluation

Case Processing and Reporting

SDM: Safety Data Management

Oracle Argus: Global Safety Database

PV System Development Consultancy

PV Project Management and SOP Development


1.    PV Medical Writing:

Safety Reports

CTA: Clinical Trial Applications

IB: Investigator Brochure

CER (Clinical Evaluation Reports)

ICSR (Integrated Clinical Statistical Reports)

REMS (Risk Evaluation & Mitigation Strategy)

RMS: Risk Management Plans

Protocols

Regulatory Briefing Documents

Formulary Dossiers
             

2.    Pharmacovigilance for Marketed Products:

EU-QPPV

PSUR/PBRER (Periodic Benefit-Risk Evaluation Report)

PADER (Periodic Adverse Drug Experience Report)

DEA (Safety Data Exchange Agreements)

PSMF (Pharmacovigilance System Master File)

Global and Local Literature Search and Review

CCSI (Company Core Safety Information)

Pharmacovigilance Training,

Pharmacovigilance Physician services

Reconciliation of ICSRs with partners

 
3.    Clinical Trial Pharmacovigilance

Medical monitoring and advice

Safety database hosting including legacy case migration

Development Safety Update Report (DSUR) preparation and submission

Global Literature Search & Review in support of the DSUR

Investigator meeting PV training

Reconciliation of Serious Adverse Events

Safety documentation storage and provision in eTMF format

Zenovel

  • IN
  • 2021
    On CPHI since
  • 1
    Certificates
  • 25 - 49
    Employees
Company types
Consultancy
Contract Service
Primary activities
Clinical Research
Medical Devices
Other
Regulatory Affairs
Specifications
  • Selling Points
    Brand Name; Convenience; Experienced Technicians; Guarantee/Warranty; International Approvals/Standards; Product Performance; Quality Service; Reputation; Sustainability
  • Supplied from
    India

Zenovel

  • IN
  • 2021
    On CPHI since
  • 1
    Certificates
  • 25 - 49
    Employees
Company types
Consultancy
Contract Service
Primary activities
Clinical Research
Medical Devices
Other
Regulatory Affairs

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