Pharmaceuticals & Biologics

Pharmaceutical QA: Understanding and Implementing ICH Q9 Guidelines

Pharmaceutical QA: Understanding and Implementing ICH Q9 Guidelines The pharmaceutical industry operates within a highly regulated framework to ensure that…

1 year ago

Understanding FDA’s Deficiency Response Letters for ANDA Submissions: A Guide to Successful Outcomes

In the pharmaceutical industry, obtaining approval from the U.S. Food and Drug Administration (FDA) for an Abbreviated New Drug Application…

1 year ago

Mastering Post-Approval Changes in Pharma: Key Strategies for Compliance and Efficiency

Navigating Post-Approval Changes: Best Practices for Regulatory Compliance: In the pharmaceutical industry, the journey of a drug doesn't end with…

1 year ago

Understanding Process Analytical Technology (PAT) Tools: Revolutionizing Pharmaceutical Manufacturing

Understanding Process Analytical Technology (PAT) Tools: Revolutionizing Pharmaceutical Manufacturing Writer : Dr Nagendraa K Singh Director & Lead Global MS&T…

1 year ago

Do you review or Do you preview ?

Do you review or Do you preview ? By Sauri Gudlavalleti Picture this: You’re stuck in traffic, late for your…

1 year ago

Process Validation in the Pharmaceutical Industry: Ensuring Consistency and Quality

Process Validation in the Pharmaceutical Industry: Ensuring Consistency and Quality Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry,…

1 year ago

What is CAPA and Why It’s Mandatory in Pharmaceuticals?

What is CAPA and Why It’s Mandatory in Pharmaceuticals? Written By : Dr. Dhriti Tupe, GxP Expert ® In the…

1 year ago

Understanding Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) in Pharmaceuticals

Understanding Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) in Pharmaceuticals Dr. Dhriti Tupe, GxP Expert ® In the…

1 year ago

Ensuring Compliance with 21 CFR Part 11 in Pharmaceuticals

Ensuring Compliance with 21 CFR Part 11 in Pharmaceuticals Written By : Dr. Dhriti Tupe, GxP Expert ® In the…

1 year ago

GLP-1 Single, Dual, and Triple Receptor Agonists for Treating Type 2 Diabetes and Obesity: A Comprehensive Narrative Review

GLP-1 Single, Dual, and Triple Receptor Agonists for Treating Type 2 Diabetes and Obesity: A Comprehensive Narrative Review Introduction The…

1 year ago