News & Events |
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This is some news. This is some news. This is some news. This is some news.
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This is some news. This is some news. This is some news. This is some news.
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Our Products
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EZeCDT - Electronic Submissions made EASY as 123!
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- What is EZeCTD?
- EZeCTD provides a set of processes and tools to ease FDA submission process.
- Provides High Quality electronic submissions in current eCTD (Electronic common technical documents) format.
- Provision for different levels of Security for both small and large companies.
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- Available in 3 Modes:
- Ala Carte Package: For a one time use KubsPharm can upload the files provided by the client and provide a CD / DVD to be submitted to the FDA. All the files have to be provided by the client in a ready to use fashion.
- Server Package: The company can log on to KubsPharma server and will be given a separate user name and password. They can upload the files and create their own submissions. The price will vary depending on the number of submissions made.
- Stand Alone Package: Complete Software package can be purchased. The software will be installed on the company server/computer.
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- Generic Drug Approval Process:
- Currently the number of applications for product approval is increasing rapidly while the number of reviewers is growing very slowly. In addition, increased applications are leading to increased supplements. Therefore the time required for approval is increasing.
- FDA is encouraging all ANDAs to be submitted in the CTD format and preferably eCTD to support Question based Application Review.
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- Salient features of eCTD submission:
- The new assessment system will focus on critical pharmaceutical quality attributes and their relevance to safety and efficacy.
- Electronic Quality Overall Summary (QOS) in Module 2 and Body of Data in Module 3 will address directly the OGD’s questions on Product quality.
- Reduced reviewer’s time spent in fact finding and elements resulting in quicker approval.
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