It is important to understand and define the clear regulatory strategies by considering the target markets/ regions, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets / regions. We provide technical support in the below mentioned areas:
- Dossier preparation & submission supported in CTD [Common Technical Document] format - Preparation of DMF [Drug Master File] and CEP [Certificate of Suitability] - Preparation of SMF [Site Master File] as per PIC/s & Local FDA requirement. - IRC [Iran Registration Code] submission
It is important to understand and define the clear regulatory strategies by considering the target markets/ regions, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets / regions. We provide technical support in the below mentioned areas:
- Dossier preparation & submission supported in CTD [Common Technical Document] format - Preparation of DMF [Drug Master File] and CEP [Certificate of Suitability] - Preparation of SMF [Site Master File] as per PIC/s & Local FDA requirement. - IRC [Iran Registration Code] submission