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.
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.
Our team of experts work with clients to provide sustainable and scalable plans for establishing and implementing quality standards.
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Assurea has launched a 2023 campaign called #RootingForYou to support and inspire women who drive innovation.
Our Latest Blogs
November 14, 2022
(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
March 21, 2022
Data integrity translates into the consistency, completeness, and accuracy of data. It is required in all aspects of biopharmaceutical development and manufacturing, including emerging technologies like block chain, as you introduce them into your Quality Management Systems. Consistency, standardization, and traceability are some of the many issues we face when it comes to data integrity. Once
December 16, 2021
Tanya Sharma, Co-Founder of Assurea LLC and Najib Rehman from ATMPS were excited when invited to join Jesse McLaughlin, host of Modern Biopharma Podcast ,to talk about how Blockchain – a new technology that is exploding in our industry – can be used to help us make a jump towards more available therapies for more