Our Main Business Courses
nPeople Software comprises of seasoned software professionals dedicated to provide a reliable and cost-effective products & services. Our Application Development model is a result of various innovations and enhancements, and is engineered to deliver a product that not only fulfills clients' requirements, but also adheres to global standards of software engineering. Though an Indian company by origin, nPeople Software has successfully adopted global IT standards.
With our in-depth domain and technical expertise and industry standard quality processes, we enable our clients to solve complex problems, mitigate risks and meet their business objectives. Our suite of application development services include:
- Brand new applications/systems development
- Major enhancements to existing applications/systems
eCTD Preparation or Compilation
We help pharmaceutical companies in submitting technical documents electronically. We produce fully validated, international regulatory compliant eCTD dossier. We provide quick and intuitive construction of complex electronic submission for any regulatory authority. nPeople is one of the very few software vendors vantaged with intellectual and effective strategic corporate level consulting and has considerable number of successful submission of eCTDs and eDMFs to its credit. Our constant consultancy makes your submissions furthermore easy.
- Submission roadmap / structure creation
- Document assembly
- Work in progress / Final preview
- Internal review
- Sequential / Parallel approval cycles
- Seamless collaboration between all key stake holders of a drug submission including author / assembler, reviewer, approver and publisher.
US FDA Submissions, ANDA, NDA, DMF etc. Submission
- Submission map creation in CTD format
- Document's granularity and life cycle management
- Dossier assembly and compilation in eCTD format
- Conversion of Paper based submission to Electronic document as required by US FDA
- Electronic Submissions gateway setup and administration
European Medicines Agency (EMEA)
Recently, EMEA has made it mandetory to submit dissiers electronically after January 1, 2010. Our consulting team carries extensive experience in providing consulting for any eSubmission made in the context of a Centralized/Decentralized/National/Mutual Recognition application procedure and the subsequent maintenance of the life cycle of the application including:
- Initial/Supplementary/Variations/Renewals application
An important component of creating a successful website is the planning process. Planning is important in order to save time and money in the actual development process. This is especially true when it comes to larger websites such as ecommerce sites, web applications or portals.
Website planning involves:
- Determining the scope of the website
- Determining the functionality of the website
- Creating a briefing document and a RFQ document for vendors.
- Creating a checklist for all aspects of the website's work.
- Creating a project plan.
A systematic approach to website planning will also help you appoint the correct vendor for each deliverable as well as budget adequately for those hidden costs that might come up later.
What we can do for you:
- Sit down with your team and understand the project requirements
- Draw up the appropriate documents to send to prospective vendors.
- Advise you on selection of vendors and job allocation.
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