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ABOUT US

Vigi Medsafe is an established Pharmacovigilance service provision company with its presence in India, Europe and the USA. It is an ISO 9001:2008 and ISO 27001:2013 certified company and combined this with its strong leadership, will ensure the following are fulfilled the first time and every time.

The company has

  • Quality Management System comprising of SOPs, Policy documents and Quality Manual
  • Comprehensive list of PV SOPs covering key components in pharmacovigilance.
  • Peer review/Quality assessment at each level to minimize errors
  • Strong in-house training covering all aspects of PV including GVP modules
  • Audit readiness – for new clients, current partners, and health authority enquiries

The company has in place

  • Highly qualified, experienced associates with pharmaceutical and medical backgrounds
  • Thoroughly trained on multiple safety and literature databases that are compliant as per HA requirements
  • Thorough analysis of cases and literature from the point of receipt/identification till reporting
  • Highly secure environment for data protection, privacy and confidentiality

Vigi Medsafe is highly educated in terms of Pharmacovigilance Regulatory compliance for

  • Various types of ICSRs in case processing
  • Submission of aggregate reports
  • Development of Risk Management plans with all appropriate sections
  • Creating company core safety information and updating all existing labels
  • Signal evaluation scheduling and submission of reports
  • Literature review and analysis

Vigi Medsafe believes in establishing strong partnerships and maintaining them by the following

  • Ensuring PV processes and systems are compliant and the partner is 24/7 ready for PV Audits and Inspections.
  • Support in Preparation of CAPA (Corrective and Preventive Action) wherever required
  • Support for PV Inspection preparation
  • Establishment of business continuity plan during unforeseen circumstances

Irrespective of prospective’s size and location, Vigi Medsafe can provide solutions that are tailored in terms of selection of databases, deployment of resources and infrastructure, operative models and delivery mechanisms.

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Vision

  • $15 million dollar company by 2020
  • Top 20 pharmacovigilance service provider
  • Global presence with strong footprint in the USA and UK
  • Increase the scope of services to include global regulatory submissions and PV audits
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Mission

  • To have a global presence addressing the needs of pharmaceutical companies and CROs irrespective of their size
  • To expand the network with like-minded organisations and build value propositions that create win-win-win situations to all
  • To implement validated state-of-art technological architectures and create an economically viable solution for all
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Values

  • “Quality” as single point agenda
  • Strict “adherence” to regulatory standards
  • “Transparent” and “tailored solutions” to partners
  • “U” is always before “I” in our value chain
  • “Satisfied” clients, partners, and all team members is paramount

2013

Vigi Medsafe was founded in Hyderabad by 4 dedicated pharmacovigilance enthusiasts from Novartis.

2013

Joint venture for training with BITS Pilani Hyderabad campus

2013

Collaboration with Techsol for Oracle’s Argus Safety

2014

1st multinational Indian generic MAH. PV system setup and performing various PV activities. Establishment of network collaboration with Dr Regenold GmbH to include EU QPPV services. 2nd multinational Indian generic MAH for comprehensive PV services. Complete PV set up to European MAH.

2015

3rd multinational Indian generic MAH for all PV services

2016

Establishment of UK / EU presence

2017

Establishment of USA office to explore new growth opportunities and deliver the same quality

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