Oviya MedSafe, a global pharmacovigilance consulting & drug safety services company based in Coimbatore in Tamil Nadu has launched a 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.

The company will also render pharmacovigilance consulting support to the regulatory agencies and the pharmaceutical industry in this region. This strategy is aimed at promoting the adoption of international standards of pharmacovigilance practices, especially among small & 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, said Dr J Vijay Venkataraman, managing director.

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 a very important market for exporters of pharmaceutical 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.

Making the announcement of this launch, Dr Vijay Venkatraman, 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 (Rest of the World) region remains a huge challenge for the pharmaceutical 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.”

The company’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.