International regulatory agencies, including the FDA, EMA, TGA, and Health Canada,
have implemented guidelines to control nitrosamine impurities in pharmaceutical
products and substances. Nitrosamines, a group of potentially carcinogenic impurities,
as well as nitrosamine drug substance-related impurities (NDSRI), can form during
manufacturing processes. Even trace amounts have prompted regulators worldwide to
closely monitor and manage their presence in drug products, including materials used
for clinical trials.
At Corealis Pharma, we are committed to guiding you through each phase of the
evaluation for the formation, presence, and, if necessary, detection and quantitation of
nitrosamines in your clinical trial materials. Our skilled team offers tailored, phase-
appropriate risk assessments and solutions, helping you seamlessly navigate the latest
regulatory requirements and expectations.
When custom analytical method development and enhanced sensitivity for nitrosamine
detection are required, Corealis can call on our network of specialized partners. They
can provide precise detection and quantification of trace impurities, supporting your
project with the highest standards of reliability and compliance.
The landscape of nitrosamine regulation in pharmaceuticals continues to evolve,
demanding comprehensive risk evaluation and access to specialized analytical
expertise. Corealis Pharma is ideally positioned to provide clients with thorough risk
assessments and, where necessary, implement control strategies to minimize the
formation of nitrosamines in the formulation.
Connect with Corealis Pharma today to ensure your clinical trial materials meet global
regulatory standards and demonstrate an unwavering commitment to safety and
compliance.
For inquiries, please contact:
Patrick Frankham, VP Business Development
Corealis Pharma Inc.
Email: patrick.frankham@corealispharma.com
Phone: +1 (450) 973-7505
www.corealispharma.com
Contact Corealis
Corealis’ experts are ready to answer any queries about the company’s oral solid dose offering, including its development and manufacturing capabilities.
