Understanding local CMC requirements in low-resource countries

International Regulatory Affairs Manager at Concept Foundation, Wallada Im-Amornphong, provides generics manufacturers with support preparing CMC dossiers for regulatory submissions in Asia and Africa. She’s currently focusing on a drug application in five different countries, with variations across dossiers. To support the manufacturer she’s working with, she prepares summary reports using Cortellis CMC Intelligence™to verify local requirements