Pharmacovigilance

Pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. We conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.

Understanding the risks and benefits associated with pharmaceutical products and food & dietary supplements, brings with it the need for more efficient and effective safety solutions.

Developing of a pharmacovigilance system and compiling the necessary risk management plans and SOPs can tie up capacities at Ruan Life Sciences Pvt Ltd. The Summary of this Pharmacovigilance System Master File (Summary-PSMF) is a necessary requirement to gain a marketing authorisation. Ruan Life Sciences Pvt Ltd provides solutions to make pharmacovigilance safe, yet easier for companies. We audit internal drug safety procedures, draft SOPs and manage appropriate risk management plans and complete pharmacovigilance systems.

Our pharmacovigilance department monitors the safety of medicinal products for many companies. Depending on a company’s needs, we can provide individual services – such as evaluating and reporting adverse drug reactions (ADRs) and severe adverse effects (SAEs) as required by law – or a complete pharmacovigliance package. One of valuable task of our pharmacovigilance department is to manage the signal services and ongoing risk/benefit analysis and assessment to ensure the constant, quality-assured and convenient monitoring of medicinal products.

Our pharmacovigilance specialists are responsible for contributing to several scientific documents – including the clinical risk management plan (RMP) – which is required during the marketing authorisation and clinical trial application processes.