Strategic and flexible outsourcing solutions to local affiliates and global pharmacovigilance departments. Whatever the needs, A-pharmaconsult offers a dedicated team to help solve your regulatory challenges in the most efficient way possible.
A-pharmaconsult offers a 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
A-pharmaconsult provides a full range of consulting services. We can provide:
A-pharmaconsult provides a full range of consulting services for Food and Food supplements. We can provide:
A-pharmaconsult provides a full range of consulting services for Cosmetics. We can provide:
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.
We hope you find our professional business skills and experience of interest to your company. You are welcome, at any time to contact us and we will arrange for an informal meeting at one of our office.