Oviya MedSafe launches Pharmacovigilance Consulting & Drug Safety service packages for RoW Region

The need for pharmacovigilance compliance in RoW assumes more significance as the demand for harmonization and implementation of regulations is growing across all markets.
By: Oviya MedSafe
 
COIMBATORE, India - Nov. 7, 2014 - PRLog -- 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 authorization holders operating in the RoW (Rest of World) region. Oviya MedSafe 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.

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 harmonization and implementation of regulations is growing across all markets.

Making the announcement of this launch, Dr J Vijay Venkatraman, Managing Director & CEO of 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 (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.”

He added, “Oviya MedSafe, with its passion for Pharmacovigilance, also understands the significance of a robust drug safety system in the context of the larger concepts of patient safety and public health. We believe that Oviya MedSafe’s strengths of meticulous knowledge of the RoW regulations, global experience, track record of quality-driven timely deliveries and cost-effectiveness by leveraging its excellence in shared services as well as hosted pharmacovigilance database systems will help in achieving our goal of providing affordable, simplified yet reliable drug safety support for the RoW region.”

Oviya MedSafe’s comprehensive service packages include assessment of the marketing authorization 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.

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About Us

Oviya MedSafe is a global Pharmacovigilance Consulting & Drug Safety Services company incorporated in India in 2012 and in the UK in 2014, offering advisory and outsourced support to the pharmaceutical industry. Oviya MedSafe is backed by 50 years of collective intelligence of its founding groups and works with renowned pharmaceutical companies and marketing authorization holders in various parts of the world.

Oviya MedSafe provides end-to-end global drug safety support (combined with regulatory-compliant drug safety database access, as required) to pharmaceutical companies with mature pharmacovigilance systems. More importantly, Oviya MedSafe comprehensively consults to generic pharmaceutical companies across the globe to help them constantly evolve their pharmacovigilance departments to be in line with the regulations pertinent to their market presence. For more details, visit www.oviyamedsafe.com.

Contact
Karthik
info@oviyamedsafe.com
+918220763222
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Source:Oviya MedSafe
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Tags:Pharmacovigilance, Drug Safety, Row, Patient Safety, Regulatory
Industry:Biotech, Medical
Location:Coimbatore - Tamil Nadu - India
Subject:Services
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