About eCTD Office
eCTD Office is a suite of three integrated NeeS / eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS / eCTD submissions of regulatory documentation by pharmaceutical companies to the regulatory authorities.
Manage your eSubmissions as simple as 1 - 2 - 3:
1. NeeS Compiler
NeeS Compiler is a next generation off-the-shelf Windows software application for building error-free non-eCTD electronic submissions. NeeS Compiler provides tools for quick and intuitive construction of complex, valid non-eCTD electronic submissions.
Veterinary VNeeS Compiler is a next generation off-the-shelf Windows software application for building error-free eSubmission for Veterinary Applications. VNeeS Compiler provides quick and intuitive construction of complex, valid electronic submission for a veterinary medicinal product: pharmaceutical or immunological.
2. eCTD Compiler
EU eCTD Compiler is a next generation off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing, manipulation and archiving system for EU electronic submissions. The main functionality of the EU eCTD Compiler is the creation of the eCTD XML backbone (+ envelope data) along with the lifecycle management.
Swiss / CH eCTD Compiler is a next generation off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing, manipulation and archiving system for Swiss electronic submissions. The main functionality of the Swiss eCTD Compiler is the creation of the eCTD XML backbone (+ envelope data) along with the lifecycle management.
3. eCTD Tools
eCTD Lifecycle helps you understand your eSubmission lifecycle and allows for easy and quick overview of your submissions history. This intuitive tool lets you speed up your submissions and manage your approvals.
MRP/DCP Tracking Table Builder is a visual Tracking Table XML builder to be used in the context of Mutual Recognition and Decentralised Procedures, under the Module 1 of the electronic Common Technical Document (eCTD) for the European Union (EU).
eChecker FREE VNeeS Validator
eCTD Office eChecker (VNeeS Validator) is a super fast and accurate, off-the-shelf veterinary electronic submissions (VNeeS) validation system. eCTD Office eChecker allows for import of the VNeeS folder / file structure to report whether the structure conforms to the VNeeS format (immunological or pharmaceutical).
eCTD Office helps you do the job...
eCTD Office applications are being used by pharma companies and pharmaceutical consultancy companies all over Europe (France, The Netherlands, Belgium, Spain, Czech Republic, Germany, UK, Bulgaria, Ireland, Norway, Cyprus, Malta, Latvia, Lithuania, Sweden, Austria, Finland, Poland, Greece, Estonia ...)