eCTD submissions are increasingly recommended and requested. US-FDA and almost all EU/EMEA drug regulatory agencies are accepting now electronic-only submissions for medicinal products for human use and are recommending the eCTD as the preferred standard.

MakroCare has powerful, feature-packed eCTD software for regulatory submissions,its document/knowledge management solution that does virtually everything from store to organize, to share & to manage your eCTD submissions quickly, efficiently, reliably and above all, securely. With our eCTD software solution we have helped and are helping many Pharmaceuticals companies to create, update, store and publish the complete set of dossier documents and manage, compile, review, register and archive eCTD submissions to regulatory agencies like US FDA, EMEA, and various other authorities.

We can also help in copying the relevant portion of previous submission to avoid duplication of work.We use a validated, proven eCTD software package for compilation of regulatory submissions and publishing

• Preparation of complete Dossiers/DMF in eCTD Format
• Ample support for Lifecycle Management
• Consultation services for Transition from paper based system to Electronic Common Technical Document (eCTD) system
• Facilitation of quick and speedy submission to help you avoid losses due to delayed submission
• Assistance by a highly trained technical team, along with the cross functional team, that can assist you in minimizing your Submission Risk