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Nitrosamine Risk Assessment: Challenges in Drug Development and Marketed Products

Auxochromofours Solutions Private Limited

Nitrosamine Risk Assessment: Challenges in Drug Development and Marketed Products

Nitrosamines have become one of the most pressing issues in pharmaceutical safety. These impurities, classified as probable carcinogens, have been detected in a wide range of drug categories, from sar...

08-Sept-2025 Toxicology

How to Ensure Regulatory Compliance in Drug Development: A Comprehensive Guide

Auxochromofours Solutions Private Limited

How to Ensure Regulatory Compliance in Drug Development: A Comprehensive Guide

Bringing a drug to market is a long, complex journey full of scientific hurdles, clinical challenges, and regulatory requirements. For biotech and pharma professionals, regulatory compliance in drug d...

08-Sept-2025 Toxicology

Facing the Future Without PFAS: Is Your Business Prepared?

Auxochromofours Solutions Private Limited

Facing the Future Without PFAS: Is Your Business Prepared?

Over the past few decades, companies across various sectors have faced ongoing challenges due to evolving regulations on the use and manufacture of certain chemicals. Today, one of the most significan...

02-Sept-2025 Success Stories

Toxicology Studies Required for FDA Drug Approval: A Complete Guide for Pharma Companies

Auxochromofours Solutions Private Limited

Toxicology Studies Required for FDA Drug Approval: A Complete Guide for Pharma Companies

Introduction For any pharmaceutical company, gaining FDA approval for a new drug is one of the most complex and resource-intensive processes. At the heart of this journey lies toxicology studies, whic...

01-Sept-2025 Toxicology

Global eCTD Regulatory Publishing & Submission Services

Auxochromofours Solutions Private Limited

Global eCTD Regulatory Publishing & Submission Services

Introduction In today’s highly regulated pharmaceutical and healthcare landscape, regulatory publishing and submission play a critical role in ensuring that life sciences companies bring their product...

01-Sept-2025 Publishing

Comprehensive Guide to Toxicology Risk Assessment for Consumer Products

Auxochromofours Solutions Private Limited

Comprehensive Guide to Toxicology Risk Assessment for Consumer Products

Every day, consumers use products like cosmetics, cleaning agents, toys, packaging materials, and personal care items without giving much thought to the safety of the ingredients inside them. But behi...

01-Sept-2025 Toxicology

Extractables & Leachables (E&L) Risk Assessment for Packaging Materials: Ensuring Safety and Compliance

Auxochromofours Solutions Private Limited

Extractables & Leachables (E&L) Risk Assessment for Packaging Materials: Ensuring Safety and Compliance

In the pharmaceutical and medical device industries, ensuring product safety and regulatory compliance is paramount. One critical aspect of this process is the Extractables & Leachables (E&L) Risk Ass...

26-Aug-2025 Toxicology

A Comprehensive Guide to Genotoxic Impurity Assessment Under ICH M7 Guidelines - Ensuring Patient Safety

Auxochromofours Solutions Private Limited

A Comprehensive Guide to Genotoxic Impurity Assessment Under ICH M7 Guidelines - Ensuring Patient Safety

In pharmaceutical development, controlling genotoxic impurities (GTIs) is a crucial step to ensure patient safety. These impurities have the potential to damage DNA even at trace levels, which increas...

26-Aug-2025 Toxicology

Ensuring Patient Safety and Regulatory Compliance: The Importance of ISO 10993-17 in Medical Device Toxicological Risk Assessment

Auxochromofours Solutions Private Limited

Ensuring Patient Safety and Regulatory Compliance: The Importance of ISO 10993-17 in Medical Device Toxicological Risk Assessment

Medical devices are at the heart of modern healthcare, saving lives and improving patient outcomes. However, their safety goes beyond performance—it’s about understanding their potential impact on pat...

26-Aug-2025 Toxicology

SEND Isn’t Optional: How to Master CDISC SEND Submissions

Auxochromofours Solutions Private Limited

SEND Isn’t Optional: How to Master CDISC SEND Submissions

Think of SEND as the “ official language ” for sharing nonclinical lab study results with regulatory agencies like the FDA (in the U.S.) or EMA (in Europe). If you’ve ever tried to send someone a file...

21-Aug-2025 SEND

Ploidy Estimation: Enhancing Precision in Plant Breeding and Selection

Auxochromofours Solutions Private Limited

Ploidy Estimation: Enhancing Precision in Plant Breeding and Selection

Ploidy estimation is the process of determining the number of complete sets of chromosomes within a cell, which is essential for assessing genomic content and stability. Ploidy estimation is an essent...

06-Aug-2025 In-Vitro Research

Cell Cycle Analysis: A Chosen Approach In Modern Research Studies

Auxochromofours Solutions Private Limited

Cell Cycle Analysis: A Chosen Approach In Modern Research Studies

Cell cycle analysis is a technique used to determine the proportion of cells within the population that are in different phases of the cell cycle (G1, S, G2, M) by measuring DNA content. Cell cycle an...

06-Aug-2025 In-Vitro Research

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