Designed for Biotech
Regulatory Affairs and Pharmacovigilance Solutions for Biotechs Entering or Expanding in New Markets.
Trusted Partner for Biotech
An operating model designed to support biotech firms entering or expanding in new territories.
Biotech companies choose Insuvia for critical regulatory compliance and pharmacovigilance support as they enter and expand in new territories. We specialize in supporting biotechs regionally and on country-level, particularly those with limited local resources or market experience, by providing an operating model tailored specifically for their unique needs.
Insuvia fully replaces the compliance functions traditionally managed by biopharma’s regional and local affiliates, delivering a seamless, comprehensive, and agile support system. Our unique combination of local expertise, robust governance, and management framework allows us to provide scalable solutions that ensure compliance and success in every territory.
Why Biotechs Choose Us
- Fast and Agile Our agile approach allows us to promptly address client needs and any unexpected issues, ensuring fast and efficient solutions that keep your projects moving forward. Insuvia prides itself on its ability to quickly adapt to changes and new requirements.
- Adaptive We understand that biotech firms require flexibility not just in project scopes but also in engagement models. Therefore, we tailor our services to meet the specific needs of each client, becoming a natural extension and integral part of their team.
- The service you expect At Insuvia, small biotech firms are our primary focus and not just another account. This focus allows us to provide dedicated support and top-tier customer service you expect.
- Efficient Our operational model is designed to provide high-quality regulatory affairs & pharmacovigilance support tailored to the unique needs of biopharma firms. By eliminating unnecessary complexity, we ensure you receive clear, efficient, and cost-effective service.
- An Extension of Your Team We aim to seamlessly integrate into your team, aligning with your systems and ways of working. Proactive and adaptive, we build trust through active contributions. By collaborating closely, we become a true extension of your team, driving shared success.
- Right-Sized for Responsiveness As a mid-sized provider with global capabilities, we are big enough to manage projects of all sizes, yet small enough to give you the personalized attention and focus you expect.
Strategic regulatory and pharmacovigilance solutions for global expansion
A Decade of Biotech Experience
3 out of 4 of our clients are biotech companies. Our extensive experience includes managing projects for various biological products such as monoclonal antibodies, cell and gene therapies, vaccines, and biosimilars. Covering both major indications and rare diseases, our expertise spans multiple therapeutic areas, providing tailored solutions to meet the unique needs of our biotech clients.
Local expertise – global capabilities
Leverage our extensive geographical coverage combined with deep country-specific expertise to navigate regulatory compliance at the regional and local affiliate level. Our resources span Europe, Eurasia & CIS, MENA, Asia Pacific, and Latin America, providing our clients with the necessary insights and capabilities to succeed globally. Our commitment to scale and adapt alongside our clients ensures robust support as you expand into new territories, offering consistent, high-quality assistance every step of the way.
Local Affiliate Services with An Integrated Cross-Functional Expertise
We provide unmatched local expertise in all compliance areas, fully substituting and enhancing traditional biopharma affiliate functions. As the sole point of contact for all local compliance needs, we simplify and streamline support for biopharma companies. This distinctive capability makes us the only provider with such extensive and effective coverage.
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Biotech Experience
A Decade of Biotech Experience
3 out of 4 of our clients are biotech companies. Our extensive experience includes managing projects for various biological products such as monoclonal antibodies, cell and gene therapies, vaccines, and biosimilars. Covering both major indications and rare diseases, our expertise spans multiple therapeutic areas, providing tailored solutions to meet the unique needs of our biotech clients.
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Global Reach
Local expertise – global capabilities
Leverage our extensive geographical coverage combined with deep country-specific expertise to navigate regulatory compliance at the regional and local affiliate level. Our resources span Europe, Eurasia & CIS, MENA, Asia Pacific, and Latin America, providing our clients with the necessary insights and capabilities to succeed globally. Our commitment to scale and adapt alongside our clients ensures robust support as you expand into new territories, offering consistent, high-quality assistance every step of the way.
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Local Affiliate Services
Local Affiliate Services with An Integrated Cross-Functional Expertise
We provide unmatched local expertise in all compliance areas, fully substituting and enhancing traditional biopharma affiliate functions. As the sole point of contact for all local compliance needs, we simplify and streamline support for biopharma companies. This distinctive capability makes us the only provider with such extensive and effective coverage.