Assurea serves as the Computer System Validation and Quality Unit for fast growing clients.
Assurea is a woman-owned boutique consulting firm known for quality compliance and computer software assurance 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.
Product Lines
Our team of experts work with clients to provide sustainable and scalable plans for establishing and implementing quality standards.
Choose what works for you
Core
Create Frameworks
$9999 /Mo
Builder
Build Frameworks
Scope of Work
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#RootingForYou
Assurea has launched a 2023 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.
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.
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
October 21, 2022
Empowering Women Entrepreneurs: Assurea is ROOTING FOR YOU!
The article highlights the persistent challenges and disparities faced by women entrepreneurs in the United States, particularly in the biotech and pharmaceutical sectors. Despite women-owned businesses accounting for 40% of US enterprises, women-led startups received only 2.3% of venture capital funding in 2020. This imbalance is further exemplified by the fact that 92% of CEOs
September 1, 2022
Assurea’s Tanya Sharma Live with Rizwan Chaudhrey
Tanya Sharma was interviewed by Rizwan Chaudhrey of the RSK Life Science Media in London during Terrapinn’s Advanced Therapies Congress in May 2022 where Assurea participated in the Startup Zone. Rizwan met Tanya Sharma again in September 2022 at the Phacilitate Advanced Therapies UK event and recorded an update on ISPE Women in Pharma and