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Elevating Cell and Gene Therapies – The Latest in Validation Innovation

Elevating Cell and Gene Therapies - The Latest in Validation Innovation, our comprehensive whitepaper designed to illuminate the forefront of validation practices within the dynamic landscape of cell and gene therapies. Here's what you'll uncover in our new white...

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Annual Submissions for US in regulatory processes 

Annual Submissions for US in regulatory processes 

Annual submissions to regulatory agencies in the US are required to maintain a product’s quality, safety, and efficacy throughout its lifecycle. These include the Annual Product Quality Reviews, Annual Safety Report, and others, each with different requirements based on the impact of changes made.

Maintaining Project Documentation and Records in Life Science

Maintaining Project Documentation and Records in Life Science

Life science companies deal with tons of data; this data could be related to processes (manufacturing, process controls, equipment, administrative, financial, legal, medical), product (physical attributes, study reports, analytical documents, batch records),...