www.productlifegroup.com Page 1 of 2 C ASE STUDY Submission Opportunities Open with Switch to ASEAN CTD THE CLIENT A French pharmaceutical company with a focus on dermatology PROJECT SCOPE The client turned to ProductLife Group for help in preparing an ASEAN (Association of Southeast Asian Nations) Common Technical Document (CTD). The company wanted to switch from an International Council for Harmonisation (now the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or ICH) dossier to the ASEAN CTD (ACTD) in an effort to achieve greater submission harmonisation. The project involved four regulatory affairs experts and two people focused on publishing activities. The project took four or five months to complete. CHALLENGES The pur

Join for free to read