Electronic Submission Services (eCTD & eSubmitter)
Just need help with electronic submissions? We are dedicated to providing the same outstanding quality of service across all electronic submissions, be it an NDA, ANDA or ANADA submission, conversion to electronic format or simply the maintenance of an existing application.
Submission Services
Our electronic submission services include:
eCTD submission outsourcing
eCTD life cycle management
Electronically File (Pharmobedient maintains a Web Trader (ESG) Account)
eSubmitter Service (author, review, publish, and package electronic CMC submissions)
Technical writing and reviewing
Regulatory strategy
Structured Product Labeling (SPL) services
Get in Touch
COMPANY
Strategy for complex issues in drug development and life-cycle management.
CONTACT
100 NE 3rd Ave, Suite 615
Fort Lauderdale FL 33301
(954) 348-9455
regulatory@pharmobedient.com