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Life Sciences Blog

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Life Sciences Blog

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Nitrosamine Impurities in Medicinal Products: Risks and Regulatory Insights 

The emergence of nitrosamine impurities In June 2018, regulatory authorities worldwide became aware of the presence of the nitrosamine ...

5 Key Toxicological Monitoring Tests for Regulatory Compliance

In an era where product safety and quality assurance are paramount,toxicological monitoring studieshave become essential for companies across industries....

Understanding REACH Registration for Chemicals in Pharma

What is REACH, and Why is it Important for Pharma and Life Sciences?

Toxicological Assessment of Extractables and Leachables (E&L)

Ensuring the safety and efficacy of pharmaceutical products involves more than just the active ingredients. The materials used in packaging and delivery...

Impact of PDE values on cleaning validation design in pharmaceutical manufacturing

Toxicology is fundamental throughout the drug life cycle, beginning with the evaluation of active substances in animals during the pre-clinical...

Safeguarding Drugs: Controlling Elemental Impurities (ICH Q3D)

Elemental impurities might not be the first thing you think of when it comes to drug safety, but they are crucial to understand. These impurities ...

Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance

“Send” – After weeks of collaboration with the operations team, legal advisors, and experts, a detailed response along with Corrective and...

Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment

As we strive to improve our health with new medicines, it’s crucial we don’t forget the impact these advances could have on the environment. The...

Toxicology Challenges in Pharma: How to Address Them?

Toxicology plays a pivotal role in the pharmaceutical industry, focusing on mitigating the adverse effects of substances on living organisms and their...
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