Experience On Demand
GlobalSubmit offers experienced, qualified consultants to assist with the full lifecycle of developing electronic submissions in compliance with ICH eCTD standards. Our consultants come from the ranks of leading corporations and offer practical skills and experience to assist you with the establishment of effective processes to ensure compliance.

We offer a comprehensive portfolio of services coupled with our regulatory submissions domain experience and industry best practices/professional services methodologies. Our in-depth knowledge and practical experience in the processes and procedures used by both the European and USA authorities help to assure your success.  Through our close association with regulatory agencies, we offer first-hand experience of successful submissions to FDA, EMEA, and other regulatory agencies.
 

eCTD Readiness Services
As of January 1, 2008, the FDA has announced their intent to enforce the acceptance of the eCTD as the preferred format for electronic submissions.  Many companies have not completed efforts to ensure their readiness.  Our services are exclusively designed to help you get ready to support the eCTD format.

Electronic Publishing Services
Electronic publishing can be a daunting task for many organizations.  We offer services to help with all aspects of assembly and publishing of the eCTD.  We offer individual consultants to augment your existing staff or ready-to-work teams that will manage your submission publishing project from start to finish.

Outsourced Solutions
Outsourcing has become mainstream and is an excellent way to overcome the eCTD learning curve and accelerate submission production.  We offer flexible programs to meet the needs of any organization.

Technology Integration Solutions
Developing eCTDs internally requires the right technology infrastructure to ensure ultimate success.  We offer comprehensive services to help you effectively establish and deploy an integrated submissions management technology environment.