• Collietech

    To be the most professional eCTD software and service provider

  • - About us -

       Suzhou Collietech Information Technology Co.,Ltd is the first independent eCTD-related software and service provider in China. Collie eCTD software series independently developed by Collietech consist of several components and have received a number of patents, of which Collie eCTD Publisher is the first and only self-developed eCTD publish software in China that has passed validation of FDA and EDQM. Currently the series have been applied by several dozen domestic and foreign pharmaceutical companies, consulting companies, and a large number of eCTD registration specialists. All of registration submissions published by Collietech eCTD software have passed validation at the first attempt. Collietech takes opportunity of implementation of eCTD in China and makes every effort to establish most professional information technology and service provider of life science area in China.

  • - Product Introduction -

    Safety Compliance Reliability High Efficiency No data breach risk

    eCTD Publisher

    eCTD publisher integrates all functions of validation and reading and supports multinational submission. It is completely designed and developed according to practical conditions and using behaviors of Chinese company users.

    eCTD Validator

    eCTD validator is an independent eCTD validation software. It perfectly satisfies regulation requirements of drug administration authorities in different countries. Validation result is accurate, compliant, reliable and efficient.

     

    eCTD Pdf Assistant

    As the first independent pdf file modifier for regulatory submission dossier, this mini software could perform massive validation and automatic modification to PDF files for submission, including correction of version, bookmarks, hyperlinks, fonds, navigate bookmarks, pages, annotations and amplification according to FDA and EU specifications respectively. It not only reduces the workload, but also considerably enhanced the efficiency of the registration unit for pharmaceutical industry.

  • - Service Mode -

    Software

    Sale

    Purchase complete software authorization + annual maintenance cost.

    Outsourcing Service

    Company provides fundamental documents and entrusts eCTD generation and publication to Collietech.

    System Customization

    Provide customized system development service for pharmaceutical companies with informatization demand.

  • Welcome Tryout : Collie eCTD Publisher

    The only completely independent eCTD publishing software passing FDA and EU registration in China

  • - Process -

    1

    Sign up

    Fill out your name, company name and contact information

    2

    Contact

    Staff will contact you within 2 workdays

    3

    Tryout

    After information confirmation demonstration is arranged for you

  • - Users and Partners -

  • Collietech eCTD software has humanized operation. Teachers from registration department provided complete technical support to our submission documents. Our problems were all solved in time, which helped us a lot.

     

    ——Liu Ling Zhejiang Ausun Pharmaceutical Co., Ltd.

    We have used many kinds of eCTD softwares. Compared to foreign software, Suzhou Collietech eCTD Publisher has the advantage of concise operation interface and simple operation. In practical using or preparation of documents we can communicate with Collietech’s regulation specialists and software engineers on any technology or software problems at any time without barrier beyond comparison with foreign software providers.

     

    ——Xue Jianjun Zhejiang Jingxin Pharmaceutical Co.,Ltd

    Operation of collietech eCTD Publisher is very simple. We independently generate eCTD documents by virtue of the software. During documents preparation process we got lots of help, allowing us to easily complete FDA Submission.

     

    ——Wong Ziyin Shanghai Wonder Pharmaceutical Co.,Ltd

  • - Contact us -

    Sign up

    Please leave your contact information or directly contact us

    E0601, Nanotech National University Science Park, 388 Ruoshui Road, Industrial Park, Suzhou
    0512-85661599
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