Blogs

IND Lifecycle Management: Key Processes and Reports

“What is an Investigational New Drug (IND) Application and When is it Required?”

What is FDA Form 483 and Why is it Important?

What are Combination Products and regulations governing them ?

Simplified Guidelines for Determining the Friability of Compressed, Uncoated Tablets

“What is the FDA Purple Book and How Does It Help?”

“How Does Japan’s Orphan Drug Designation Process Work?”

Responsibilities and Roles of Quality Assurance Department

Concept of Deviation

Pharmaceutical Sweeteners

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