For all your Regulatory Submission needs
Datafarm provides a comprehensive set of regulatory submission solutions to meet the needs of all sizes of life sciences companies.
In addition to providing industry-leading software and software technical support, Datafarm can provide you with onsite or remote regulatory operations services.
Standards and Formats
It is our goal to cover all required formats and standards across the world, in order to assist sponsor organizations with their regulatory submission efforts.
Our Solutions/Products support the following standards:
- CTD
- eCTD
- NeeS/vNeeS
- ACTD
- CDISC - SDTM/ADaM
- Labeling - SPL/PLR/PIM
Our Solutions/Products support the following formats:
- Electronic
- Paper
The Datafarm R&D team is currently working on the following new/upcoming standards/formats:
- RPS
- eStability
Software
Datafarm's suite of software solutions support the entire electronic regulatory submission process, from authoring documents, publishing PDFs and preparing clinical data, through compiling and validating eCTD, Non-eCTD Electronic Submissions (NeeS) and Paper submissions for those agencies that require paper format.
- Server based Solutions – for large and medium size companies
- Desktop based Solutions – for start-ups and small size companies
Services
Datafarm's regulatory services provide a multi-faceted approach to meet all your regulatory submission needs, from support on day-to-day tasks to implementing long-term solutions for your business needs.
- Regulatory Operations
- Technology Services
Designed For Efficiency
Datafarm Services 
- Submission Component
Preparation - eCTD/NeeS/Paper Publishing
- SPL & PLR Labeling Conversion
Services - PIM Labeling Services
- FDA Submission Data (CRT)
Preparation Services - CDISC/FDA Submission Data
Conversion Services - Consultation, Training & Education
- eCTD infrastructure development
Datafarm Products