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Regulatory Affairs
Regulatory Affairs
Comprehensive Regulatory Support for Global Compliance
Delivering end-to-end regulatory services to ensure successful product development, market approval, and ongoing regulatory compliance across all territories.
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Pharmacovigilance
Pharmacovigilance
Integrated Safety Management from Development to Market
Delivering end-to-end pharmacovigilance services to ensure the highest standards of drug safety and regulatory compliance globally.
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Local Affiliate Services
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Company
Company
Excellence in Pharmacovigilance & Regulatory Affairs
Superior quality pharmacovigilance and regulatory affairs services helping the pharmaceutical industry make safe and effective healthcare products available worldwide.
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About us

Insuvia – a prominent leader in pharmacovigilance and regulatory affairs services industry

Who we are

Insuvia is designed to act as a pharmacovigilance and regulatory affairs unit for pharmaceutical companies in those countries and regions, where they have no internal structures or decide to focus their resources on commercial activities.

In this context, we provide the regional and country-level expertise to solve all pharmacovigilance and regulatory affairs challenges that pharmaceutical companies encounter while commercializing their products.
  • Designed for Biotech

    For biopharma companies entering or expanding in new markets, Insuvia is the go-to partner for regulatory compliance and strategic market access. Insuvia is specifically designed to substitute the compliance functions of regional and local affiliates, offering a seamless, comprehensive, and agile support system.

  • Exceptional Local Presence

    We specialize in country-level operations. As part of this differentiation, we have built a local presence that is second to none. That means local resources who understand your business, local and international requirements and the specifics of the industry.

Our guiding principles
  • Vision
    To be the global partner of choice for pharmaceutical companies, easing regulatory navigation and ensuring patients have timely access to the medicines they need.
  • Mission
    Help the pharmaceutical industry make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.
Core values at Insuvia

Driven by our core values, we continually strive to set new standards in pharmacovigilance and regulatory affairs.

  • Collaboration We work collaboratively with each other and with our clients to achieve success together.
  • Initiative We are proactive and take initiative to solve problems and get things done. We embrace challenges and drive progress.
  • Ambition We pursue excellence, set ambitious goals, and constantly strive to exceed expectations in everything we do.
  • Integrity We believe in doing the right thing. We're honest, transparent, and accountable for our actions.
Ethical conduct

Integrity is not just a value we hold; it is the essence of who we are. 

While striving for exceptional business results, we equally prioritize the manner in which we achieve them. Holding the highest standards of ethical conduct has guided every action and decision, fueling Insuvia's success and earning the trust and respect of our clients, employees, and partners.

Company History

We have grown to an international organization by expanding to new territories step-by-step.

This bottom-up approach has provided us with a unique understanding of each activity we are involved in, of each territory we operate in, as well as of the challenges our clients and industry face. This was the foundation that made us who we are today – a prominent leader in the pharmacovigilance and regulatory affairs services industry, helping the pharmaceutical industry make safe and effective healthcare products available worldwide.

Insuvia start 2014
2014
Company start
Establishing a company and starting to provide country-level outsourcing services for the pharmaceutical industry in the Baltic region.
2015-2017
Building Up & Perfecting Operational Model
Identifying the gap in the market, building up and perfecting our operational model to offer fully integrated and unified pharmacovigilance and regulatory affairs operations on an international level.
2018-2019
Geographical Expansion
Expanding our well-established operational model to other territories in Europe and the rest of world. By the end of 2019 our operations already cover Europe, CIS, and MENA territories.
2022
ISO 9001:2015 Certified
Our Quality Management System was ISO 9001:2015 certified by TÜV Thüringen for the scope of: Pharmacovigilance services, Regulatory Affairs services, Clinical Research services.
2023
Fastest Growing Company in Europe 2023
Insuvia listed among the 1000 fastest-growing companies in Europe, coming in at 367th place in the 2023 ranking by the Financial Times & Statista.
2024
Fastest Growing Company in Europe 2024
Securing the #282 spot in the Financial Times & Statista’s 2024 ranking of Europe’s fastest-growing companies, a marked improvement from #367 in 2023, and making it to the list for the second consecutive year.
Insuvia start 2014
2014
Company start
Establishing a company and starting to provide country-level outsourcing services for the pharmaceutical industry in the Baltic region.
2015-2017
Building Up & Perfecting Operational Model
Identifying the gap in the market, building up and perfecting our operational model to offer fully integrated and unified pharmacovigilance and regulatory affairs operations on an international level.
2018-2019
Geographical Expansion
Expanding our well-established operational model to other territories in Europe and the rest of world. By the end of 2019 our operations already cover Europe, CIS, and MENA territories.
2022
ISO 9001:2015 Certified
Our Quality Management System was ISO 9001:2015 certified by TÜV Thüringen for the scope of: Pharmacovigilance services, Regulatory Affairs services, Clinical Research services.
2023
Fastest Growing Company in Europe 2023
Insuvia listed among the 1000 fastest-growing companies in Europe, coming in at 367th place in the 2023 ranking by the Financial Times & Statista.
2024
Fastest Growing Company in Europe 2024
Securing the #282 spot in the Financial Times & Statista’s 2024 ranking of Europe’s fastest-growing companies, a marked improvement from #367 in 2023, and making it to the list for the second consecutive year.
Insuvia start 2014
2014
Company start
Establishing a company and starting to provide country-level outsourcing services for the pharmaceutical industry in the Baltic region.
2015-2017
Building Up & Perfecting Operational Model
Identifying the gap in the market, building up and perfecting our operational model to offer fully integrated and unified pharmacovigilance and regulatory affairs operations on an international level.
2018-2019
Geographical Expansion
Expanding our well-established operational model to other territories in Europe and the rest of world. By the end of 2019 our operations already cover Europe, CIS, and MENA territories.
2022
ISO 9001:2015 Certified
Our Quality Management System was ISO 9001:2015 certified by TÜV Thüringen for the scope of: Pharmacovigilance services, Regulatory Affairs services, Clinical Research services.
2023
Fastest Growing Company in Europe 2023
Insuvia listed among the 1000 fastest-growing companies in Europe, coming in at 367th place in the 2023 ranking by the Financial Times & Statista.
2024
Fastest Growing Company in Europe 2024
Securing the #282 spot in the Financial Times & Statista’s 2024 ranking of Europe’s fastest-growing companies, a marked improvement from #367 in 2023, and making it to the list for the second consecutive year.
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Recognition and awards

Recognized Excellence: Our Certifications, Awards, and Global Accomplishments

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