Auxochromofours Solutions Private Limited Planning for SEND From Day One: A Complete Guide for Sponsors and CROs In our first post, we explained why SEND (Standard for Exchange of Nonclinical Data) is no longer optional in regulatory submissions. Agencies like the FDA and PMDA now mandate SEND datasets to ensure...
Auxochromofours Solutions Private Limited Non-Clinical Toxicology Requirements for IND and NDA Submissions Every drug begins with promise, but before it can reach patients, regulators must be assured of its safety. This assurance comes from non-clinical toxicology studies, the cornerstone of preclinical dr...
Auxochromofours Solutions Private Limited Why GLP-Compliant Toxicology Testing Matters More Than You Think In the world of drug development, safety is non-negotiable. Every decision, every milestone, and every regulatory submission depends on one crucial factor trustworthy toxicology reports. But ensuring ...
Auxochromofours Solutions Private Limited 8 Key Global Regulatory Challenges in the Pharmaceutical Industry Innovation in the pharmaceutical industry doesn’t stop at borders neither should compliance. Today, drugs are developed, tested, manufactured, and marketed across multiple countries. For example, a dr...
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...
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...
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...
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...
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...
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...
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...
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...
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