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),
PSUR generation and prompt submission to Competent Authorities,