Electronic Common Technical Document (eCTD)- Submission/Software
Common Technical Document is an industry standard document in Pharmaceutical industry adopted by US, EU, Canada and Japan for regulatory submission. eCTD is an electronic version of CTD.
eCTD is an interface for Pharmaceutical industry to agency transfer of regulatory information. Here eCTD is not limited to transfer of information it also considers creation, review, life cycle management and archival of electronic submission. It facilitates paperless submission to the respective authorities.
Challenges Faced in Implementing eCTD
- Business Process needs revision
- Infrastructure needs to be updated
- Personnel needs to be trained
- High Investment and Maintance Cost in purchasing and adopting the system
We Add Value by
- Preparation of Complete Dossier in eCTD Format.
- Conversion of CTD format to eCTD format by using our software.
- Complete support for Managing the lifecycle of eCTD.
- Consultation on Transition from paper based system to Electronic Common Technical Document (eCTD) system.
Who will be beneficial from our eCTD Consultation
- Small Companies having 5-10 submission in a year - High investment and Maintenance of system can be a costly affair.
- Pharmaceutical Companies - Looking for transition from paper based system to eCTD
- Companies who want quick and speedy submission - Avoiding losses arriving as a result of delayed submission.
Our Highly trained technical team along with latest technological support Work to Minimize Your Submission Risk and get you faster market access.
eCTD Resources
Email Us info@perfect-consultants.com gupta1@vsnl.com
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