Introduction: FDA Peptide Sameness Study Requirements define the scientific and regulatory framework needed to demonstrate that a generic synthetic peptide […]
Regulatory Requirements for Peptide Sameness Study (FDA & Health Canada) Read More »
Introduction: Why Nitrosamine Testing Highly Potent APIs Requires Specialized Expertise Nitrosamine Testing Highly Potent APIs demands highly sensitive analytical methods,
Nitrosamine Testing in Controlled Substances and Highly Potent APIs (HPAPIs) Read More »
Introduction: Applying a Nitrosamine Reformulation Strategy Without Compromising Bioequivalence A structured Nitrosamine Reformulation Strategy can block nitrosamine formation pathways while
Introduction: Peptide Sameness vs Biosimilar Comparability is one of the most misunderstood concepts in modern pharmaceutical development. While both involve
Peptide Sameness Study vs Biosimilar Comparability: What’s the Difference? Read More »
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 »
