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Our latest blog uncovers how to meet ICH Q3D guidelines with ease using our new tool Vitic Q3D.

Avoid unnecessary testing: Achieve confident ICH Q3D compliance using regulatory aligned consortium data

News, Innovate /

Approaching regulatory compliance with confidence ICH Q3D guidelines require assessing and controlling elemental impurities for regulatory compliant development of drug products. The workflow emphasises a risk-based control strategy to limit elemental impurities, which can be derived from residual catalysts, raw materials, reagents that can be present in the API or excipient of the drug product. […]

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ICH Q3E - what the new guidelines mean for you

ICH Q3E – what the new E&L draft guideline means for you

Discuss, News /

The release of the ICH Q3E for public consultation marks a significant milestone for the pharmaceutical industry. It sets out a harmonised, risk-based framework for the assessment and control of organic impurities that migrate from packaging or manufacturing components into a final drug. For years, organisations navigated a complex web of regional expectations for extractables

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Understanding nitrosourea Acceptable Intake limits via read-across

Navigating the EMA guidelines: Understanding nitrosourea acceptable intake limits via read-across methods

Innovate, News /

In the ever-evolving landscape of pharmaceutical regulations, staying abreast of the latest guidelines is crucial for ensuring the safety and efficacy of drug products. Recently, the European Medicines Agency (EMA) updated its guidelines to include specific nitrosourea acceptable intake (AI) limits – a class of N-nitroso compounds known for their potential carcinogenicity. In our recent

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Growing Lhasa: Welcoming Molecular Networks and Altamira

Growing Lhasa: Welcoming Molecular Networks and Altamira

Life at Lhasa, News /

We’re delighted to announce that Molecular Networks and Altamira (MN-AM) have joined our organisation! This marks an important step forward in our mission to advance chemical safety science and reduce the need for animal testing. Building on strong foundations This acquisition builds upon an established partnership – we’ve collaborated closely with both teams for years,

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Where can N-Nitrosamine data support an alternative AI beyond the CPCA?

Where can N-Nitrosamine data support an alternative AI beyond the CPCA?

Discuss, News /

The recently published paper “Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes,” presents evidence for evolving the pharmaceutical industry’s approach to N-nitrosamine risk assessment. While the Carcinogenic Potency Categorisation Approach (CPCA) has provided a solid framework for managing N-nitrosamine drug substance-related

Where can N-Nitrosamine data support an alternative AI beyond the CPCA? Read More »