Our services
Your expert partner for confident safety and regulatory decisions
Whether you are progressing a development candidate, responding to regulatory questions, or working with limited resources, chemical safety decisions must be supported by clear, scientifically grounded evidence for submission.
Consult Lhasa provides expert-led risk assessments that combine in silico approaches with trusted scientific and regulatory expertise. Our consultants deliver structured, reproducible outputs designed to help you understand risk, prioritise next steps, and move forward with confidence.
Assess your potential toxicological risk early
Screen your compounds quickly to gain early indicators of safety and make informed decisions without relying on in vitro or in vivo testing.
In silico toxicology screening brings together predictive toxicology, metabolism, and degradation into a structured assessment, so you can understand how your compounds are likely to behave in a biological context.
Results are clear and easy to interpret, to support confident prioritisation. Expert-led insights highlight where further assessment will add value, and where to focus effort across your workflow in line with regulatory expectations.
Risk assessment services
Where focused assessment is needed, we provide expert support across key regulatory and scientific risk areas.
Impurity formation
Establish whether impurity levels are acceptable and define appropriate control strategies to support product safety and progression.
Potentially mutagenic impurities
Classify potentially mutagenic impurities in line with ICH M7 and define acceptable limits and control strategies with expert review built in.
Extractables
and
leachables
Assess extractable and leachable risk to support patient safety, product quality and regulatory expectations under evolving ICH Q3E guidance.
Nitrosamines
Assess nitrosamine formation risk, establish potency where needed, and support acceptable intake strategies in line with current regulatory expectations.
Non-mutagenic impurities
Define safe limits for non-mutagenic impurities and contaminants using weight-of-evidence assessments to support control strategies and regulatory justification.
Consult an expert
Discuss your specific requirements with our experts. Whether you need targeted regulatory support, additional resources, or input beyond the services outlined.
Why choose Consult Lhasa?
Early-stage decision support
Data gap identification and justification
Regulatory-aligned risk assessment
Defensible submissions and responses
“Our experience with Consult Lhasa has been very positive, resulting in a final report that we are confident will meet the scope required by regulatory agencies. The Consult Lhasa team are knowledgeable about the regulatory needs of the region, particularly Brazil, and provide great support. Their consulting has been invaluable to our company, the technical, scientific and human exchange has been impeccable. We are very satisfied with the collaboration.”
Adriana Tomalino, Head of Regulatory Affairs at Triquim
“We recently had the experience of collaborating with Consult Lhasa to address an EU regulatory deficiency on a potential degradation impurity of the drug substance. Consult Lhasa made an intriguing task look simple in the final report which was based on Zeneth, literature review and expert analysis. Their professionalism and commitment to excellence were truly commendable and their proactive approach made the entire process seamless and ensured that we met the stringent regulatory timelines. Their core scientific knowledge, hands-on experience with the pharmaceutical industry and caliber of their work make them a standout choice. It is evident that they take great pride in what they do, and this pride reflects in the exceptional quality of their work. We strongly recommend Consult Lhasa to anyone seeking expert advice on API degradation profile, drug-excipient compatibility, leachables & extractables, potentially mutagenic and non-mutagenic impurities and most importantly the nitrosamine impurities.”
Muzaffar Khan, Senior General Manager within Regulatory Affairs at Laurus Labs Limited
“We recently had the opportunity to collaborate with Consult Lhasa on the AI/ limit derivation of a new NDSRI. Given the challenge of limited specific data available for the queried nitrosamine, we sought Consult Lhasa’s expertise to enhance the robustness of our Read-Across approach. Their work is referenced in the latest global regulatory updates on nitrosamines, and this high level of scientific rigor was clearly reflected in their deliverables.
We sincerely thank the team for their deep scientific knowledge, timely efforts, and outstanding support.
We highly recommend Consult Lhasa and look forward to another productive collaboration in the future.”
Eleni Politi, Chemistry, Manufacturing and Controls/Safety Toxicologist at Rontis Hellas
Consult an expert
Discover how Consult Lhasa can improve your scientific risk assessments through a free, no obligation, expert consultation.