Our offers

PV & QPPV

  • PV System set-up
  • QPPV
  • PV Database
  • PV Audits
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Clinical Trial

  • Clinical Safety
  • Medical Monitoring
  • Compliance Monitoring
  • Customer Response
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Marketing Authorization

  • MA Application
  • Marketing Supprot
  • T&T Support
  • Regulatory Intelligence
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Post Authorization

  • Local PV Represntation
  • Literature Screening
  • Local RA support
  • Lifecycle Management
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Main advantages

Pre-Authorization

Regulatory strategy & dossier GAP analysis for API , Finished products and Medical devices, dossier submission and follow up upto the process completion.

Post-Authorization

Distributor search & marketing support, regulatory inteligence, medicinal product life cycle management

Pharmacovigilance

Pharmacovigilance rpresentation and 24/7 support , PVsystem setup & QPPV, PV audit & database, global and local literature screening .

Clinical Trial

Local support in clinical safety, medical monitoring for finished medicinal product and medical instruments.

Product Promotion

Cooperation with distributor,polyclinics and hospitals for product promotion in the market.

Other Services

Company representation, customer support, translation service etc.