Electronic & Paper Submission Services
OmniASSIST™ provides a full range of consulting and implementation best practices for compiling electronic, paper, or hybrid submission for worldwide regulatory agencies. The team has a proven track record of successfully filed, compliant submissions.
OmniASSIST™ offers the following electronic & paper submission services:
- Define paper, hybrid, and electronic submission processes
- Develop strategic and staffing plans
- Develop presentations for FDA demonstrations
- Develop responses to FDA regulatory submission-related questions
- Coordinate data and document deliverables from CROs
- Identify, qualify and manage high-speed print vendors
- Implement and validate OmniTEMPLATE and OmniFILE
- Develop and implement customer on-site training programs related to electronic submission activities
- Build compliant electronic submissions - eCTD, eNDA, Amendments, and Supplements
- Build compliant electronic reports - Clinical, Nonclinical, Human PK, etc.
- Electronically build compliant paper submissions - IND, CTX, CTA, ANDA, NDA, BLA, MAA, NDS, CTD, 510K, PMA, Amendments, and Supplements
- Electronically build compliant paper reports - Laboratory, Clinical, Nonclinical, Human PK, etc.
- Develop and implement 21 CFR Part 11 programs
- Assist with post-submission filings
- Perform knowledge transfer
OmniASSIST™ has skilled professionals and proven technology (OmniFILE) to complete any type of submission: paper, electronic, or hybrid.
OmniASSIST™ is all about bringing the right people to complete your submission and document project needs on time, while respecting your budget.
Click here to request additional information on Omnicia's professional services offering or send us an email at sales@omniciainc.com.