Excellence in Pharmacovigilance & Regulatory Affairs
Superior quality pharmacovigilance and regulatory affairs services helping the pharmaceutical industry make safe and effective healthcare products available worldwide.
Services for Every Step of Your Journey - From Development to Market, Both Globally and Locally.
We guide biopharmaceutical companies through the regulatory landscape, ensuring compliance at every stage of the product lifecycle. We offer strategic planning, expert regulatory guidance, and risk mitigation through due diligence and compliance management. With country-specific expertise, we help clients navigate local regulations, ensuring adherence and accelerating market access.
We ensure product safety and regulatory compliance across the entire lifecycle, from clinical trial safety to post-approval pharmacovigilance. With a strong local presence in key markets, we provide comprehensive services, including essential EU-QPPV office support, as well as LPPVs and local PV services across global territories. This enables our clients to maintain the highest safety standards and meet all regulatory requirements both globally and locally.
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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Regulatory Affairs
We guide biopharmaceutical companies through the regulatory landscape, ensuring compliance at every stage of the product lifecycle. We offer strategic planning, expert regulatory guidance, and risk mitigation through due diligence and compliance management. With country-specific expertise, we help clients navigate local regulations, ensuring adherence and accelerating market access.
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Pharmacovigilance
We ensure product safety and regulatory compliance across the entire lifecycle, from clinical trial safety to post-approval pharmacovigilance. With a strong local presence in key markets, we provide comprehensive services, including essential EU-QPPV office support, as well as LPPVs and local PV services across global territories. This enables our clients to maintain the highest safety standards and meet all regulatory requirements both globally and locally.
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Local Affiliate Services
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.
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.
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.
Designed for Biotech
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.
Facts & Figures
The Numbers Behind Our Success
- 90% Staff with a life-science background
- 100+ Global clients trust us
- 90% Repeat business and referral rate for clients
Our Achievements
Recognized Excellence: Our Certifications, Awards, and Global Accomplishments
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