>> ELECTRONIC REGULATORY SUBMISSIONS

Compliance Associates recognizes the requirements and challenges that the International Conference for Harmonization's (ICH) Common Technical Document (CTD) and e-CTD may present to our clients and hence has available the skill sets, knowledge base, and tools to provide valuable solutions to our clients in meeting these regulations. Our consultants possess an in-depth knowledge of all regulations and standards governing the submission process. This coupled with their extensive knowledge in the types of studies and trials in drug development, provides our clients with a solution to expedite submission approval.

Our proven solutions include:

 • Making use of our client's existing technology by performing thorough analysis, identifying gaps,
     and improving process methodologies
 • Implementing processes that will allow you to meet current and future requirements.
 • Implementing new technology and processes with a futuristic view.
 • Ensuring submissions are in available in both CTD and e-CTD formats.

Our practical approach includes:

 • Identifying and qualifying submission data input systems
 • Evaluating, and / or implementing organization data management systems
 • Creating required document templates
 • Developing and implementing organization document workflow
 • Qualifying electronic submission process
 • Generating pilot submission in CTD and e-CTD format