Customer Requirement: An animal product company, based in Ireland, wanted to file an abbreviated new animal drug application (ANADA) with the United States Food and Drug administration (US FDA) for its non-steroidal anti-inflammatory drug (NSAID) product. The drug is used to relieve pain and inflammation that is associated with osteoarthritis & control post-operative pain in dogs. The company required a comprehensive assessment and compliance check to ensure the product dosser met all applicable and relevant regulatory standards and data requirements.
Problem Statement: After conducting a dossier review, it was discovered that a crucial component of the drug product’s composition, a wax ingredient integral to the drug formulation, failed to meet stability data requirements due to its susceptibility to melting.
The key objective was to ensure stability data requirements were fulfilled in order to proceed with successful ANADA filing.
DDReg’s Solutions & Processes Adopted: The team at DDReg conducted thorough regulatory assessment to understand the stability data requirements and identify non-compliance related to the ingredient. They sought scientific advice from the US FDA through its local agent and liaised with the customer to generate stability data including providing potential reformulation strategies or stabilization techniques which could address the stability issue while ensuring compliance. After the client generated the data, the regulatory team at DDReg conducted in-depth review to ensure the data was in line with the US FDA requirement and the recommendation from the scientific committee. They updated the product dossier with revised formulation details, stability testing results, and other technical documentation and prepared & submitted the regulatory documents including supplementary information. The team put together the submission package and uploaded it on the electronic portal on the US FDA website for animal health products.
Achievement & Business Impact: By addressing the stability issue and ensuring compliance with stability data requirements through scientific advice from the US FDA, DDReg ensured the product dossier met the applicable regulations and standards for successful ANADA filing. As a result, the animal product company came back to DDReg for more regulatory work regarding their animal health product portfolio.