eCTD Dossier Preparation or Compilation Service
eCTD Dossier (DMF, ANDA, NDA etc)
The eCTD is an interface for the pharmaceutical industry to transfer regulatory information with various regulatory agencies. The content is based on the Common Technical Document (CTD) format.
It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).
The US FDA and Europe EMEA announced that the eCTD is the preferred format for electronic submission (eSubmisson) of Drug Dossiers. The drug manufacturer has to submit the drug dossier in eCTD format.
The eCTD Dossier contains following modules:
Fig: eCTD Dossier Structure
- Module 1 - Administrative Information and Prescribing Information
- Module 2 - Common Technical Document Summaries
- Module 3 - Quality
- Module 4 - Nonclinical Study Reports
- Module 5 - Clinical Study Reports
The CTD defines the content only of the common modules (M2 to M5). However, the contents of the Module 1 (Regional Module) are defined by each of the ICH regions (USA, Europe and Japan).
eCTD Dossier Preparation
The eCTD is a message specification for the transfer of Drug Dossier information from a submitter to a receiver in electronic form. The primary technical components are as follows:
Fig: eCTD Dossier Folder Structure
- A high level folder structure (required)
- An optional lower level folder structure
- Recommended files name
- Associated Document Type Definitions (DTDs) and stylesheets
The eCTD Dossier Preparation is a bit complex process as the dossier has to comply with the Regulatory Standard and eCTD specification.
Our regulatory affair team has ample expertise & experience of eCTD Dossier Preparation which will help you at every step of eCTD life cycle. Our constant consultancy will makes dossier Preparation & its submissions furthermore easy. You don't need to worry about eCTD standard & regional guidelines. We would love to help you in eCTD Dossier Preparation and its submission to regulatory authorities.
- Our eCTD Dossier Preparation team produces fully validated, international regulatory compliant eCTD Dossier.
- We provide quick and intuitive Preparation of complex electronic dossier for any regulatory authority.
- Our constant consultancy will makes dossier Preparation & its submissions furthermore easy.
eCTD Preparation & Submission Services
Here is the list of Preparation & Submission related Services we offer:
- eCTD Dossier Preparation (New/Amendments) & Submission for registering products in markets like EU, USA and MCC countries.
- Drug Master File (DMF) Dossier Preparation for open and closed part.
- Preparation of pre-clinical & clinical overviews through literature search/published studies/articles from different sources.
- Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
- Critical documents review including MBR/BMR to make them comply with regulatory expectations.
- Support in analytical method development / validation, Routine analyses of products by HPLC/GC/MS etc. techniques, Product characterization and Impurity profiling at our associate company.
- Support in responding to queries asked by Regulatory Agencies.
Tags: eCTD dossier submissions , CTD & eCTD Submissions , Regulatory compliant dossier Submissions , US FDA Submissions , EMEA Submissions , ANDA submissions , Regional (Canada, EU, US) support , Electronic Common Technical Documenr (eCTD), CTD Format eCTD Dossier Format & Structure eCTD Dossier Preparation & Submission Service