Smooth Drug Development provides pharmacovigilance services after the drug registration.
Pharmacovigilance is the pharmacological activities relating to the collection, detection, assessment, monitoring and prevention of adverse effects with pharmaceutical products as patients protection.
Our specialists monitor pharmacological efficacy and safety in accordance with the requirements of the Good Pharmacovigilance Practices (GVP) and applicable regulations. The pharmacovigilance system is a part of the company's Quality Management System, all activities are carried out in accordance with the Standard Operating Procedures.
We offer the following services:
- Development of the pharmacovigilance system master file (PSMF)
- Development of the Risk Management Systems and Plans (RMP)
- Providing a hotline for doctors and patients
- Collect information on product safety in the literature and the Internet
- Analysis of individual case safety reports (ICSRs)
- Coding medical terms in accordance with MedDRA
- Preparation of urgent reports on Adverse Reactions (AR)
- Development of Periodic safety update reports (PSUR)
- Provision of urgent and periodic reports to regulatory bodies
- Conducting Post-authorisation safety studies (PASS)
Smooth Drug Development has been providing pharmacovigilance services since 2014.