We support our clients with a complete set of safety strategy and PV obligations compliance services. Whether that means helping clients establish a global quality PV system, developing procedures and key documents, ensuring recurring activities, or assisting in solving any other PV requirement. We believe in team work by gaps analysis followed by offering tailored solutions to meet the clients’ niche requirements.
We support our clients with a complete set of Pharmacovigilance obligations compliance services. Whether that means helping clients establish a global quality PV system or ensuring recurring activities.
PharmaVigil team prepares complete life-cycle of a regulatory dossier, supporting all the major steps in the preparation of a submission, liaison with the regulators for and on-behalf of our clients.
We develop clinical study/BA-BE study protocols, clinical study reports, clinical patient safety narratives, investigator brochures, Informed consent forms, Clinical Overview (CO), Non-Clinical Overview (NCO), AtCO and other documents.
Our team is qualified and experienced in toxicological risk assessment and has helped products pass the rigorous regulatory scrutiny and reach the market.