eCTD Preparation & Submissions
The preparation and submission of regulatory information in the standard electronic Common Technical Document (eCTD) format is a critical step in the regulatory approval process for new drugs and medical devices, and it requires a significant investment of time, resources, and expertise.
The process involves gathering of enormous amout of information from clinical trials that accounts for the safety, efficacy, and overall risk-benefit quality of the medicinal product. Most global regulatory agencies such as US FDA (USA), EMA (EU), Health Canada (Canada), TGA (Australia), Japan’s MHLW, and few other health authorities have mandated eCTD for regulatory submissions making it a globally accepted submission format.
With over 15+ years experience, our medical writing team has helped several pharma and medical device companies to timely complete the preparation, review and submission of eCTDs for different types of regulatory approvals.
Our eCTD Preparation & Submission Services
eCTD Preparation for Applications & Submissions
We have the expertise to assemble all the required documentation for preparing eCTDs related to the following:
- Investigational New Drug (INDs)
- New Drug Applications (NDAs)
- Abbreviated New Drug Applications (ANDAs)
- Biologics License Applications (BLAs)
- Drug Master Files (DMF)
eCTD Validation & Submitting Test Samples
Prior to a final submission our team will complete the following activities:
> Verify the eCTD against the applicable Specifications for eCTD Validation Criteria (FDA) , TGA Validation Criteria or EU-Validation Criteria.
> Complete a test submission to applicable agencies as per mandated instructions (FDA, EMA)