-
Product Development
-
Clinical Trials
-
Quality
-
GxP Audits
-
Regulatory Affairs
-
Pre-authorisation
- Regulatory Roadmap
- Scientific Advice
-
Product information
-
Dossier preparation
- Dossier Gap Analysis
- MA Handling
- Post-authorisation
- Regulatory outsourcing
-
Pre-authorisation
-
Pharmacovigilance
-
QP Service / Importer
Pharmacovigilance system (PSMF)
Pharmacovigilance is the process of monitoring the safety of medicines. Marketing Authorization Holders (MAHs) have a legal obligation to set up and maintain a Pharmacovigilance system. Our team possesses appropriate knowledge and experience relating to the detection, assessment, understanding and prevention of adverse effects. SciencePharma has developed full pharmacovigilance system as described in Good Pharmacovigilance Practices (GVP) including all quality aspects and offers it to clients. Each company is implemented to our Pharmacovigilance System which is compliant with EU requirements.
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.
We offer a comprehensive or partial services in the field of Pharmacovigilance.