Auxochromofours Solutions Private Limited The Future of SEND - Global Expansion and Digital Submissions SEND's Growing Global Relevance While SEND (Standard for Exchange of Nonclinical Data) originated as a U.S. FDA requirement, its global expansion is accelerating as other regulatory agencies explore t...
Auxochromofours Solutions Private Limited In-Vitro Research Services for Early-Stage Drug Discovery: Benefits and Applications What is In-Vitro Research in Drug Discovery? In-vitro research refers to studying biological processes outside a living organism, usually in controlled lab settings like test tubes, petri dishes, or c...
Auxochromofours Solutions Private Limited REACH and Toxicology Risk Assessment – A Guide for Manufacturers In today’s global chemical industry, manufacturers face increasing pressure to comply with international regulations and ensure product safety. Among these, REACH regulations and toxicology risk asses...
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Auxochromofours Solutions Private Limited Common Pitfalls in SEND Submissions and How to Avoid Them While the U.S. FDA continues to mandate SEND for nonclinical study data, other regulatory agencies are also taking notice. The European Medicines Agency (EMA) has launched a proof-of-concept pilot (Ja...
Auxochromofours Solutions Private Limited The Journey of eCTD and Artificial Intelligence in Regulatory Submission Publishing In the global life sciences industry, regulatory submissions are the bridge between innovation and patient access. A successful submission ensures that new medicines, biologics, or medical devices can...
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Auxochromofours Solutions Private Limited What is Computer System Validation (CSV) in Pharma? In today’s pharmaceutical, biotechnology, and healthcare industries, computerized systems play an essential role in managing critical processes from drug manufacturing to laboratory testing and qualit...
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...
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