ABOUT US

Digital Experts.
Real Impact.

We are a Digital Implementation partner that helps biotech companies set up and validate digital systems, ensure digital compliance and build custom AI solutions.

We support organizations across the life sciences ecosystem from fast growing biotech and pharma companies and CDMOs to medical devices, GxP software, and emerging technology providers.

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Technology People Better Outcomes
Assurea
at a Glance
2021
Founded
North Carolina
Headquarters
USA | Europe | India
Global Presence
Women & Minority Owned
Ownership
Life Sciences
Industry Focus

Why We’re Here

As Assurea grows, we are committed to expanding our global impact in STEM,
using technology to solve real problems and create waves of positive change.

People
Progress
Possibility

What Makes Assurea Different

Hyper Focused
On digital implementation and validation.
Specialists, not Generalists
Practical, experienced support with clear pricing.
No Cookie Cutter Solutions
No fluff. Just real solutions that drive momentum.
We Don’t Leave When the Project Ends
We stay through handover, audits and whatever comes next.
The Right Team
Experts who execute — no layers, no handovers, no diluted accountability.
Simple & in Plain English
Clear communication at every step.

Meet the People Behind Assurea

Tanya Sharma

Tanya Sharma
Co-Founder
Tanya thrives on possibility. With a background in bioprocessing and chemical engineering, she has built her career across digital transformation, validation, and emerging technologies. She leads digital implementation and modern data initiatives at Assurea and is a contributing author to ISPE’s GAMP 5 2nd Edition.

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Krisha Patel

Krisha Patel
Co-Founder
Krisha brings clarity, structure and momentum to the work that matters. With a degree in Bioprocessing Science and Food Science and extensive experience in validation and quality assurance, she leads validation, IT infrastructure, AI, and quality compliance initiatives at Assurea.

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David Nugent
David Nugent
Business Development
David is usually one of the first people our clients meet. He is approachable and straightforward, with experience across software assurance, GxP compliance, validation, and IT governance. He connects clients with the right expertise.
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Nika Ketsbaia
Nika Ketsbaia
Business Development
Nika brings energy, curiosity and a fresh perspective to Assurea’s business development team. With degrees in Accounting/Finance and Marketing/Sales, he builds new relationships and leads our Convos & Croissants series.
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Jayvee Mamuyac

Jayvee Mamuyac
Principal Consultant, Digital Implementation, Validation, and Quality
Jayvee is the kind of person clients trust to take a project from start to finish, with experience across Veeva, Maximo, ComplianceQuest, MES, and Empower. He leads digital validation projects end to end at Assurea.

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Aakash Agarwal

Aakash Agarwal
Principal Consultant, Digital Implementation, Validation, and Quality

Aakash is the person you want in the room when a project has a lot of moving parts. With a background in laboratory systems across LabVantage LIMS, Veeva, and TrackWise, he supports digital implementation, CSV, and AI validation projects at Assurea.

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Avtandil Ketsbaia
Avtandil Ketsbaia
Principal Consultant, AI and GxP Implementation
Avtandil enjoys being at the edge of what’s changing, energized by what AI can bring to life sciences. His experience spans computer system validation, quality assurance, and data integrity, supporting CSV and QA initiatives at Assurea.
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Marcelo Gallardo
Marcelo Gallardo
Consultant – CQV/CSV
Marcelo has a natural way of connecting with people wherever the project takes him. A Biotechnology Engineer with CQV and CSV experience across the U.S., Europe, and LATAM, he supports validation projects from planning through execution at Assurea.
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Let’s Build What’s Next
Whether you’re implementing your first digital system or scaling your global operations, we’re here to help.
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