Pharmacovigilance (PV) plays a vital role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Therefore, here at Adore Research Pvt. Ltd, we provide complete solutions and services for Pharmacovigilance where Our Team will support in writing Pharmacovigilance Report (abbreviated PV or PhV). Relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short-term side effects of medicines.
Our Team shall collect the data, monitor, research, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbals and traditional medicines. Identifying new information about hazards associated with medicines preventing harm to patients. Our Pharmacovigilance services include:
•Development of Pharmacovigilance System Master File (PSMF).
•Development of Pharmacovigilance System Procedures
•Develop Safety Data Exchange Agreements and assist in sign off with all your licencing partners e.g. distributor, manufacturers, vendors.
•Assist in day to day operational and strategic process e.g. handling regulatory queries, inputs and inspections.
•Support for auditing & inspection of Pharmacovigilance activities (in case of inspection or audit by our foreign partner firms or by authorities).
= Global literature Search üProcessing of Individual Case Safety Reports (ICSRs)
= Preparation of Risk Management Plan (RMP)
= Preparation of Periodic Safety Update Report (PSUR)
= preparation of Queries/Deficiencies Response