Assurea serves as the Computer System Validation and Quality Unit for fast growing clients.
Assurea is a woman-owned consulting firm known for quality compliance and computer system validation expertise within global life sciences industry. We have built a model that is collaborative, flexible and accelerates the path forward for our partners to serve patients in need.
Our Expertise
Assurea is committed to helping you every step of the way no matter where you are in your product lifecycle or in the world! With our expertise, we help our clients navigate complex regulations and evolving infrastructure in a dynamic environment.
Service Lines
Our team of experts work with clients to provide sustainable and scalable plans for establishing and implementing quality standards.
Contact Us to learn more about our services.
#RootingForYou
Assurea has launched a campaign called #RootingForYou to support and inspire women who drive innovation.
Our Latest Blogs
September 7, 2023
Assurea: Founding Member of Women in Advanced Therapies (WIAT)
Rizwan Chaudhrey interviews Assurea’s Tanya Sharma, Catapult‘s Fernanda Masri, and Phacilitate‘s Becky Johnson-Kent at WIAT (#ATE2023) to get their perspective on the impact of Women in Advanced Therapies and what learnings they had gained from attending the WIAT event in Portugal.
August 17, 2023
Building a Biotechnology Business While Helping Women Shine
Tanya Sharma expressed her views on women in the pharma industry in this detailed article by Bioprocess International. Read more below as she shares the current landscape for women entrepreneurs and the shift needed in the pharma and biotech industry. Women make up a significant percentage of the people who have established careers in the
July 13, 2023
Cell and Gene Therapy Distributed and Point-of-Care Manufacturing: Building Infrastructure and Capacity
Hear from our Co-founder, Krisha Patel, and CEO of Cellular Origins, Edwin Stone as they discuss the current challenges in building infrastructure and capacity for cell and gene therapy in this panel hosted by Carol Houts, CSO at Germfree. 📹 📢 Key Discussions:🔹 The use of automation tools and robotic solutions that support scale-up activities.
March 7, 2023
From Start-up to Staple: RegMedNet Interviews Tanya Sharma
To celebrate International Women’s Day (8 March) and acknowledge the often challenging career path taken by women in science, RegMedNet spoke to Tanya Sharma, co-founder of Assurea (NC, USA) about her inspirations as a woman in science, the resources and mentors she draws upon to support her professional journey and how learning from her mentors
November 18, 2022
Women Leading Validation Podcast: Assurea
Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Assurea’s Co-Founders, Tanya Sharma and Krisha Patel on the Women Leading Validation Podcast. They discuss their entrepreneurial journeys and share the Assurea story. They also share their perspectives on the current challenges and barriers in the biotech industry around digital compliance and the adoption of novel technologies. Listen to
November 14, 2022
Assurea’s co-founder is on a mission to elevate women in Pharma
(By Brian Buntz) Tanya Sharma, co-founder of the consulting firm Assurea LLC, helps clients in the life sciences industry navigate regulatory requirements. Sharma is an advocate for women in STEM and the life sciences. Sharma: I came to the U.S. when I was five years old and became interested in biomanufacturing. I worked in the labs