Product Safety services

Strategic and flexible outsourcing solutions to local affiliates and global pharmacovigilance departments. Whatever the needs, A-consult group offers a dedicated team to help solve your regulatory challenges in the most efficient way possible. 

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Product Safety - Drugs

A-consult group offers a full range of consulting services within Pharmacovigilance. Whether you are a global pharmacovigilance department or a locale affiliate, we have the staff to support you and deliver individually tailored solutions depending on your need.

Within Clinical Trial Safety we can provide:

  • Adverse Event Management, including collection, data entry, assessment and reporting to regulatory authorities and Ethics Committees

  • Establishment and operations of Data Monitoring Committees/Data and Safety Monitoring Boards

  • Writing and updates of reference safety information (i.e. safety sections in Investigator’s Brochure)

  • Preparation of DSURs and aggregated SUSAR reports

  • Input to safety sections in clinical trial protocols

  • Training of investigators, monitors, CRAs

  • Pharmacovigilance audits

 

Within Post-marketing Safety we can provide

  • A full outsourcing solution of your Pharmacovigilance system

  • QPPV and/or Deputy QPPV function

  • Adverse Event Management, including collection, data entry, assessment and reporting to regulatory authorities and other parties, as applicable

  • Literature surveillance

  • Medical evaluation

  • Signal detection, validation and communication to regulatory authorities

  • Preparation or review of PSURs/PBRERs

  • Preparation and updates of Risk Management Plans, and monitoring of risk minimisation activities

  • Preparation and updates of reference safety information (CCSI)

  • Input and review of protocols for post-authorisation safety studies (PASS)

  • Pharmacovigilance Agreements and Safety Data Exchange Agreements

  • Establishment and maintenance of Pharmacovigilance System Master File(s)

  • Registration with EudraVigilance and XEVMPD

  • Pharmacovigilance audits

  • PV QA and training

  • Training in use of MedDRA

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Product Safety - Food and Food supplements

A-consult group provides a full range of consulting services for Food and Food supplements. We can provide:

  • Evaluation of product safety (HACCP)
  • Evaluation of promotional materials

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Product Safety - Cosmetics

A-consult group provides a full range of consulting services for Cosmetics. We can provide:

  • Expertise in the evaluation of product
  • Writing of product labelling
  • Evaluation of promotional material
  • Writing of dossiers for Cosmetics including Safety reports, according to EU current regulations
  • Notification to the Authorities.

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Product Safety - IDMP

Identification of Medicinal Products, also called IDMP, is expected to be enforced by the European Medicines Agency (EMA) in 2017. This will require suppliers and especial marketing authorization holders to deliver IDMP compliant data to EMA and National Authorities in connection with ex. submission of new marketing Authorizations Applications and Variation Applications in beginning of 2019. 

 

The IDMP is safety driven and a project owned by the authorities and applies for medicinal products for both human and veterinary use.

  • IDMP Compliance Strategy
  • Project Management
  • Supplier Assesment
  • Collection of Data
  • Data Entry
  • Data Import
  • Writing of SOP’s

 

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