Datafarm is pleased to announce a new innovative service that leverages Datafarm’s extensive Regulatory expertise. The Regulatory Support service, offered as an annual subscription service, presents our experienced Regulatory Submission professionals to assist you by telephone or e-mail.  The Datafarm consultants have extensive knowledge of all of your regulatory operations: submission planning, implementation and delivery. 

The service includes:

• PDF publishing support for issues and/or questions
• Issues and/or questions related eCTD and Lifecycle management
• Advice on document structure, granularity and placement within the eCTD dossier for ICH modules as wells US, EU, MHLW and HC regional modules

In addition to keeping abreast and disseminating current information in an ever-changing regulatory environment, we provide interpretation of guidelines and specifications as well as training and educational courses based on eCTD regulations.

Our expertise includes availability as your technical representative for agency communications pertaining to electronic components of all investigational and marketing applications.

Our service features offers a special “How Do I?” series of questions and answers specifically related to electronic regulatory submissions.   Upon pre-arrangements, individual site visits can be scheduled. Supplementing the Regulatory Support service Datafarm has established a web-based forum for Datafarm customers to share their experiences and knowledge. In summary Datafarm offers an on-demand service which is just part of our commitment to the industry and customers.