Dossier
Pharmaceutical dossier is highly detailed and exhaustive document on the drug which requires extensive datas on its various aspects.
Pharmaceutical dossier is highly detailed and exhaustive document on the drug which requires extensive datas on its various aspects.
| Why Registration of Medicines Required? |
| Due to enormous number of medicines available worldwide, countries have enforce registration procedures for regulating quality. Company registration process is a preceding step for the registration process of medicines. With our contacts we can facilitate both company registration and registration of medicine. |
| Pharma Dossier Writing |
| Dossier compilation requires skills of sourcing, interpreting and writing this document. The systematic procedure is highly time consuming and costly. For this pharma dossier compilation and writing please feel free to contact us |
| Pharma CTD / ACTD/eCTD Dossier |
| There is two types of dossier namely CTD ( Common Technical Dossier) and ACTD ( Asian Common Technical Dossier ). Regulated pharma markets (eg.USA, Europe ) markets require submission of dossier in CTD format which has to provide clinical trial and bioequivalence studies. As against this, semi-regulated pharma markets (South East Asian and Gulf Countries) require ACTD format which does not require exhaustive details like CTD. Many companies are compilling electronic dossiers for submission in various regulated or semi regulated countries |
| Procedures |
| Nowadays Regulatory affairs become a key factor for medicines approval and marketing in any other countries. So it becomes very crucial for all the companies. Pharmaceutical consulting for the registration procedures is expensive. For these regulatory affairs pharmaceutical dossiers are key factors wherein we offer our drug regulatory consulting services. |
