PHARMACOVIGILANCE

PHARMACOVIGILANCE
Product Description

SciencePharma has developed full Pharmacovigilance system as described in Good Pharmacovigilance Practices (GVP) including all quality aspects and offers it to clients. We offer a comprehensive or partial services in the field of Pharmacovigilance.Our experienced, eager for knowledge team ensures:

  • Comprehensive individual case safety reports management (receipt, tracking, processing, MedDRA coding, medical analysis and assessment, follow-up, reporting)
  • Signal detection
  • PSUR generation and prompt submission to Competent Authorities
  • Preparation of Addendum to Clinical Overview
  • Performing of weekly literature searches
  • Consulting or complete registration of MAH to EudraVigilance
  • Ensuring of responsible person for the purposes of EudraVigilance activities
  • Electronic reporting to EMA and competent authorities (via EVWEB or company’s gateway)
  • Entering and maintaining of product information in XEVMPD
  • Preparation of Pharmacovigilance System Master File (PSMF) tailored to company's needs
  • Preparation of Risk-management plans for specific products (Module 1.8.2 of registration dossier)
  • Pharmacovigilance audits aiming at assessment of company's system, indicating deficiencies and advise on needed and/or proposed improvements
  • Acting as Local Pharmacovigilance Contact points to ensure compliance with polish requirements

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SciencePharma

  • PL
  • 2018
    On CPHI since
  • 50 - 99
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Primary activities
Chemical Development
Clinical Research
Contract Research Organisation
Medical Devices
Other
Regulatory Affairs
View company profile
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SciencePharma

  • PL
  • 2018
    On CPHI since
  • 50 - 99
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Primary activities
Chemical Development
Clinical Research
Contract Research Organisation
Medical Devices
Other
Regulatory Affairs
View company profile

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SciencePharma resources (2)

  • BOTULINUM NEUROTOXINS TYPE A AND B

    News BOTULINUM NEUROTOXINS TYPE A AND B

    SciencePharma, acting on behalf of its client - Nova Pharma Sp. z o.o., would like to kindly invite you to negotiate rights acquisition to the documentation of development of the method for the production and purification of botulinum neurotoxins type A and B.
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    2 Feb 2024
  • REGULATORY AFFAIRS SERVICES

    Brochure REGULATORY AFFAIRS SERVICES

    SciencePharma offers multidisciplinary services covering all aspects of regulatory affairs including pre-authorisation, post-authorisation as well as handling of registration process of medicinal products (human/veterinary) and medical devices across all application types and various pharmaceutical forms. We can also support you in placing dietary supplements or cosmetics on a market.