As COFEPRIS advances to Stage 2 (confirmation) and Stage 3 (mitigation) of its national nitrosamine risk management strategy, pharmaceutical companies in Mexico face increasing pressure to validate their analytical methods and implement robust mitigation plans. With these changes creating immediate regulatory urgency, Lambda Científica, a Tentamus Company, is stepping up to guide the industry with proven expertise.
At a recent International Society for Pharmaceutical Engineering (ISPE) forum, Lambda Científica shared key insights into the complexities of nitrosamine testing. One of our top experts delivered a specialized presentation focused on confirmatory analysis, drawing from years of hands-on laboratory experience.
“At the ISPE forum, our goal was to share practical insights that empower pharmaceutical companies to strengthen their nitrosamine testing programs,” said Mauricio Ibarmea, Deputy General Director at Lambda Científica. “By drawing from real-world experience in our laboratories, we aim to contribute to higher standards of analytical excellence across the industry.”
The session highlighted the technical hurdles that pharmaceutical manufacturers often face, from analytical method validation to mitigation planning, reinforcing Lambda Científica’s role as a trusted technical partner during this evolving regulatory moment.
With deep expertise in Mexico’s regulatory landscape and cutting-edge analytical capabilities, Lambda Científica is uniquely positioned to support pharmaceutical companies as they navigate COFEPRIS’s evolving nitrosamine requirements. Our team offers specialized confirmatory testing, strategic regulatory guidance, and a collaborative, solutions-oriented approach to help ensure compliance, protect product integrity, and stay ahead of regulatory expectations.
About Tentamus North America
Tentamus North America is part of the Tentamus Group, a global network of highly accredited laboratories offering a wide range of analytical testing and consulting services focused on quality and safety. In North America, Tentamus labs provide expert testing solutions for industries including food and feed, pharmaceuticals, cosmetics, agriculture, and the environment. Committed to scientific excellence and customer service, Tentamus North America partners with clients to ensure product safety, regulatory compliance, and risk mitigation.
Partner with us to move forward with confidence.
Contact our team today to learn how Lambda Científica can support your nitrosamine strategy.
ventas@lablambda.com.mx
At a recent International Society for Pharmaceutical Engineering (ISPE) forum, Lambda Científica shared key insights into the complexities of nitrosamine testing. One of our top experts delivered a specialized presentation focused on confirmatory analysis, drawing from years of hands-on laboratory experience.
“At the ISPE forum, our goal was to share practical insights that empower pharmaceutical companies to strengthen their nitrosamine testing programs,” said Mauricio Ibarmea, Deputy General Director at Lambda Científica. “By drawing from real-world experience in our laboratories, we aim to contribute to higher standards of analytical excellence across the industry.”
The session highlighted the technical hurdles that pharmaceutical manufacturers often face, from analytical method validation to mitigation planning, reinforcing Lambda Científica’s role as a trusted technical partner during this evolving regulatory moment.
With deep expertise in Mexico’s regulatory landscape and cutting-edge analytical capabilities, Lambda Científica is uniquely positioned to support pharmaceutical companies as they navigate COFEPRIS’s evolving nitrosamine requirements. Our team offers specialized confirmatory testing, strategic regulatory guidance, and a collaborative, solutions-oriented approach to help ensure compliance, protect product integrity, and stay ahead of regulatory expectations.
About Tentamus North America
Tentamus North America is part of the Tentamus Group, a global network of highly accredited laboratories offering a wide range of analytical testing and consulting services focused on quality and safety. In North America, Tentamus labs provide expert testing solutions for industries including food and feed, pharmaceuticals, cosmetics, agriculture, and the environment. Committed to scientific excellence and customer service, Tentamus North America partners with clients to ensure product safety, regulatory compliance, and risk mitigation.
Partner with us to move forward with confidence.
Contact our team today to learn how Lambda Científica can support your nitrosamine strategy.
ventas@lablambda.com.mx
