June 13, 2024
FDA Warning Letters: How To Respond
In the complex landscape of regulatory oversight in the United [...]
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Industry Articles
May 19, 2024
What Is A User Requirements Specification [URS]?
By clearly defining user requirements in the user requirement [...]
May 9, 2024
Most Popular FDA 483 Observations: 2024 Edition
For companies operating in industries regulated by the Food and [...]
April 25, 2024
Case Study: Mastering Manufacturing Compliance
About The Client Compliance Team worked with a manufacturer of [...]
April 11, 2024
GMP Vs. cGMP: What Is The Difference?
Many who participate in the manufacturing of medical products may [...]
April 4, 2024
What is CQV Validation? How To Ensure Quality & Compliance.
In industries like pharmaceuticals, biotechnology, and medical [...]
March 28, 2024
New Drug Development: What To Do Internally & What To Outsource
Technology startups in pharmaceutical production have numerous [...]
March 14, 2024
FDA Cosmetic Regulations: New Mandated Compliance Programs For Cosmetic Companies
In Mid-December 2023, the FDA published its final guidance under [...]
February 29, 2024
Why Should You Outsource Quality Audits?
Our Compliance Team review of the 2023 most frequently cited 483 [...]