Introduction In this NDMA Root Cause Investigation Case Study, we examine a real-world scenario involving an unexpected spike of N-nitrosodimethylamine […]
Case Study: Root Cause Investigation of Unexpected NDMA Spike in Finished Product Read More »
Introduction Nitrosamine Testing CRO Selection requires detailed scientific evaluation and regulatory awareness. Global authorities continue to update nitrosamine guidance, and
Selecting the Right Nitrosamine Testing CRO: A Technical Due Diligence Checklist Read More »
Introduction: Semaglutide Sameness Evaluation for Health Canada is a scientifically rigorous analytical process required to demonstrate that a generic semaglutide
Introduction: Why Specialized Peptide Oligonucleotide Conjugate Analysis Is Essential Peptide Oligonucleotide Conjugate Analysis is critical because peptide–oligonucleotide conjugates (POCs) combine
Analytical Testing Services for Peptide-Oligonucleotide Conjugates Read More »
Introduction: The global pharmaceutical industry is facing strict regulatory control for mutagenic impurities, especially nitrosamines. A strong understanding of NDA
NDA vs ANDA Nitrosamine Data Requirements: What Sponsors Must Submit Read More »
Introduction A comprehensive Nitrosamine Risk Assessment for ANDA Submission requires a structured and scientific evaluation of potential nitrosamine formation pathways.
How to Prepare a Complete Nitrosamine Risk Assessment Report for ANDA Submission Read More »
Introduction Nitrosamine Testing in Stability Studies is no longer limited to initial risk mitigation. It has evolved into an ongoing,
Nitrosamine Testing in Stability Studies: Designing Long-Term Monitoring Programs Read More »
Introduction: Peptide Sameness Testing Methods are advanced analytical strategies used to demonstrate that a generic or follow-on peptide drug is
Analytical Techniques Used in Peptide Sameness Testing Read More »
Introduction Selecting a Reliable CRO for Generic Drugs becomes more challenging when dealing with advanced or non-traditional formulations. Unlike simple
What Makes a CRO Reliable for Complex Generic Molecules? Read More »
Introduction Analytical Method Development for Generic Drugs is one of the most important scientific and regulatory steps in the ANDA
Analytical Method Development for Generic Drugs: CRO vs In-House Lab Read More »
