Freyr has won a regulatory services contract from a $600+ Mn global South Korean pharma client, another strategic win in the new globally emerging growth markets. Under the terms of the contract, Freyr will be engaged to embark on a suite of activities including end-to-end dossier management, publishing and submission of key active API’s (DMF) predominantly for the US market.
Project scope will also include undertaking gap analysis and conversion of paper DMF to eCTD format and submission through Freyr’s electronic gateway. It will also involve allocation of new DMF number, US agent authorization services and generation of FEI number.
Work on the project will soon commence and is anticipated to be complete by early next year. Freyr will work towards improving regulatory compliance and enhance project delivery while standardizing regulatory operations and achieve scale within the company’s operations.