Pharmacovigilance solutions

Global, regional and local pharmacovigilance solutions blended into a seamless product safety management system under our unified governance model. We help pharmaceutical companies assure the safety of their products and achieve regulatory compliance of their pharmacovigilance systems. Discover our Pharmacovigilance and Regulatory Affairs solutions

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Regulatory solutions

From regulatory strategy and dossier development to product registration and full life-cycle management activities. We help pharmaceutical companies overcome critical regulatory challenges and provide them ongoing hands-on regulatory support assuring maximum compliance and timely approvals. Discover our Pharmacovigilance and Regulatory solutions

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Outsourcing solutions:

Local regulatory support to assure regulatory compliance and maintain licences through product life-cycle.
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Country-level pharmacovigilance systems and local QPPVs to assure safety compliance in individual countries.
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Regulatory strategy and marketing authorization services aimed to achieve fast and smooth regulatory approvals.
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Medical writing and Dossier development services covering all documents from Module 1 to Module 5.
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Global pharmacovigilance system, including all pharmacovigilance processes and activities to assure compliance and patient safety.
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Full safety management solution for products undergoing clinical trials. We support all aspects of clinical pharmacovigilance.
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Countries We Cover

By providing Pharmacovigilance and Regulatory solutions to our clients we combine local expertise with international reach
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Excellence in Pharmacovigilance and Regulatory Affairs services

We provide regional and country-level expertise assuring pharmacovigilance and regulatory  excellence and compliance while empowering pharmaceutical companies to focus on commercializing their products.

+370 37 247 902

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