P R A C T I S I N G

S A F E T Y

www.oviyamedsafe.com

O V I Y A M E D S A F EC O N T A C T

INDIA

www.oviyamedsafe.com

Practising Safety

Oviya MedSafe Pvt Ltd

2nd Floor, KTVR Gardens

220a-3, Marudha Konar Road

Velandipalayam

Coimbatore - 641 025

Tamil Nadu, India

Oviya MedSafe UK Ltd

Suite LP25393

20-22, Wenlock Road

London

N1 7GU

United Kingdom

UNITED KINGDOM

:Tel +91-422-2444442 :Tel +44-8452-733839

STAY CONNECTED

www.facebook.com/OviyaMedSafe

www.twitter.com/OviyaMedSafe

www.linkedin.com/company/oviya-medsafe

REACH US

info@oviyamedsafe.com

+91-422-4203993

www.oviyamedsafe.com

P O R T F O L I O

About UsOviya MedSafe is a Pharmacovigilance Consulting & Drug Safety Services company with expertise in providing end-to-end pharmacovigilance support across the globe. Our team of well-experienced professionals with diverse and complementary technical backgrounds in medicine, pharmacy and nursing are geared up to deliver the highest quality of pharmacovigilance services that cater the needs of the clients.

Our Roots

Oviya MedSafe was formed in 2012 as an extension of the diverse portfolios in which our founding groups have excelled collectively for more than 50 years. Through our wide and extensive experience in healthcare, education, outsourcing and management industries, we are committed to proactively support the growth of drug safety practices across the globe.

Mantra

About Our Hometown

S E R V I C E S

The Need

The regulatory requirements for medicinal products have changed from purely passive monitoring and reacting to alerts to a proactive and patient-centered approach. Therefore, the regulations on drug safety monitoring have become more stringent, mandating companies to carry out more pharmacovigilance activities, leading to dramatic cost increases to pharmaceutical companies, which can be minimized by smart outsourcing.

Expertise

Oviya MedSafe has established and set itself alone as a company providing pharmacovigilance consulting and drug safety services. Efficient infrastructure, industry best practices and keeping phase with regulatory and corporate compliance makes us a compelling choice for partnerships.

As a team of entrepreneurs, physicians, healthcare professionals and acclaimed business leaders, we are committed to deliver high-quality, cost-efficient service. Beyond that as a full-service based firm, Oviya MedSafe is configured to be your strategic partner pursing sustainable competitive advantage.

We inculcate the pharmacovigilant culture in our team – which we take pride in acknowledging as our success mantra. Ample knowledge and relevant skills empower us to provide advice and assistance on various facets of pharmacovigilance. We believe in customer service and satisfaction through our industry-valued standards and by nurturing long-term, engaged and mutually beneficial partnerships. Our experience, professionalism and energy set Oviya MedSafe's standards of unparalleled commitment and flexible approach.

Surrounded by the Western Ghats and often referred to as the Manchester of South India, Coimbatore is the sixteenth largest urban agglomeration of India. Establishing itself as one of the fastest growing cities in India, Coimbatore is a major textile, industrial, commercial, educational, information technology, healthcare and manufacturing hub of Southern India. Coimbatore has been ranked 4th among Indian cities in investment climate by the Confederation of Indian Industry (CII) and ranked 17th among the top global outsourcing cities by Tholons. Coimbatore has sister city relationships with Toledo in the United States and Esslingen in Germany.

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www.oviyamedsafe.com www.oviyamedsafe.com

ü

Instructions & Guidance Assistance

ü Audit & Inspection Support

ü Training & Consultancy

ü Evolving & Implementing CAPAs

ü Regulatory Safety Assistance

ü Expert Clinician Panel Support

ü Medical Information - Call Centre Support

ü Pharmacovigilance System Master File Preparation

ü Pharmacovigilance Database Consulting

ü Turnkey Projects in Pharmacovigilance

Standard Operating Procedures, Work

Pharmacovigilance Consulting

ü End-to-end Processing & Submission of

Individual Case Safety Reports (ICSRs)

ü Aggregate Report Writing & Review

(PSURs / PBRERs, PADERs, Clinical

Overview Documents & DSURs)

ü Preparing PSURs for Submission to the

Drug Controller General of India

ü Comprehensive Pharmacovigilance

Service Packages for the RoW Region

ü European Union Qualified Person for

Pharmacovigilance (EU QPPV) and

Local Responsible Person (LRP) Services

ü Risk Management Plans (RMPs) &

Risk Evaluation and Mitigation Strategies

ü Global & Local Literature Monitoring

ü Signal Detection, Assessment & Management

ü Clinical Trial Safety Management

ü Medical Device Vigilance

Drug Safety Services