The strategy is aimed at promoting the adoption of international standards of pharmacovigilance practices
Oviya MedSafe, a global pharmacovigilance consulting & drug safety services company based out of Coimbatore, India and London, UK has launched comprehensive drug safety service packages in line with the compliance requirements for pharmaceutical companies and marketing authorisation holders operating in the RoW (Rest of World) region.
Oviya MedSafe will also render pharmacovigilance consulting support to the regulatory agencies and the pharma industry in this region. This strategy is aimed at promoting the adoption of international standards of pharmacovigilance practices, especially among small and mid-sized innovators and generic drug marketers of any size in the fast-emerging RoW region, by fulfilling their end-to-end drug safety obligations in an economical and efficient manner.
The term RoW region, traditionally meant to refer to the countries in the Asia Pacific, Latin American, Eastern Europe, African and Middle East regions, is an important market for exporters of pharma products and medical devices globally, in terms of business expansion and revenue. The need for pharmacovigilance compliance in RoW assumes more significance as the demand for harmonisation and implementation of regulations is growing across all markets.
Dr J Vijay Venkatraman, Managing Director and Chief Executive Officer, Oviya MedSafe said, “Drug safety regulations across the globe are becoming more and more stringent, especially in the emerging markets. While drug safety systems geared to comply with stringent regulations are already in vogue in developed countries, establishing such systems in the RoW region remains a huge challenge for the pharma industry due to various reasons such as relative unavailability of relevant expertise, differences in regulatory requirements within the RoW countries, limited budget allocations for pharmacovigilance activities and so on.”
Oviya MedSafe’s comprehensive service packages include assessment of the marketing authorisation holders’ obligations and execution of the applicable pharmacovigilance tasks such as adverse event reporting (including electronic submissions where required), literature monitoring, aggregate reporting, risk management planning, signal detection and any other services, as appropriate.
EP News Bureau – Mumbai