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:

N

eCTD submission outsourcing

N

eCTD life cycle management

N

Electronically File (Pharmobedient maintains a Web Trader (ESG) Account)

N

eSubmitter Service (author, review, publish, and package electronic CMC submissions)

N

Technical writing and reviewing

N

Regulatory strategy

N

Structured Product Labeling (SPL) services

Get in Touch

13 + 3 =

COMPANY

Strategy for complex issues in drug development and life-cycle management.

CONTACT

642 NE 3rd Avenue
Fort Lauderdale FL 33304

TEL. #

(954) 348-9455