Soon FDA will stop accepting paper submissions of all kinds of applications. Despite there being extensive information available from FDA and other regulatory bodies regarding eCTD submission, creating one and submitting it through the electronic submission gateway (ESG) of the FDA, is a daunting task even for those proficient in computer systems and coding languages. The off-the-shelf software and consultations available are prohibitively expensive not only in the capital investment required but also in terms of the time needed for getting a submission ready.
Who will Benefit:
Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
Medical and Technical writers
Project Managers, Directors
Supervisors, and lead workers in Regulatory Affairs
Quality Assurance and Quality Control
Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.