Buying eCTD Software vs
Outsourcing eCTD submissions
08th Feb 2016
I Sumit
Gupta
As of 4th October 2013
U.S. FDA has seen 19771 application in eCTD format and with
time eCTD has been widely accepted by the industry.Coming
5th May 2017 eCTD submission for new DMFs wil be mandatory
in eCTD format and all subsequent amendments and annual
reports for all the DMFs will be in eCTD format only.
Early adopters have already geared themselves for the eCTD regulations, but the early majority is still in the transition phase and this phase has brought forward a very import question of To Buy the software & implement the system or simply get the same outsourced to an Professional Service provider. ???? This question is of great importance as the Pharma Industry is run by various segments like Bulk Drug Manufacturers ( filing type II US DMF), Primary Packaging Material Manufacturer ( Filing type III US DMF) , Excipient Manufacturer ( Filing type IV US DMF ) all these segments will be directly affected by these changes in regulation and they will need to comply with them come 5th May 2017.
We in this write up are looking to help you with this decision by discussing the various Positives and negatives of both these options.
The first option
Postives of Buying eCTD software
1) The System is at your
own premises so you can plan your own submission dates
without relying on any third party.
2) Data is Stored on your own Systems so it is safe and
confidential
3) Company with huge volumes (more than 25) of submission can
see this as an investment with reasonable payback period .
4) Life Cycle management of submissions becomes easy and
submission timelines can be reduced with well trained
manpower and efficient software
The Down Side of buying eCTD software
1) Buying eCTD Software
is not only buying one software, you will need to buy a good
PDF converter , document management software with templates
for easy filling of the submission cost of these additional
dependent software's can raise the bill of investment to a
greater level.
2) It is not only buying, but maintaining this software with
frequent updates will attract significant cost of up to 20%
of software billing amount.
3) Specialized systems require trained manpower, companies
will have to shell out extra bit of money on training
existing staff with new systems or look to hire trained
experts
4) Payback period on the investment can be very lengthy for
Small companies who have less than 10 submissions annually.
Outsourcing has been the BUZZ word , with so many companies outsourcing many processes to cross countries, cities and within cities also. Outsourcing has always helped in reducing 2 things
"TIME & MONEY"
Sometimes it just logical to outsource so companies can concentrate on their core competency, in the case of eCTD outsourcing, it ticks all the right boxes Logical, Money and time saving.
1) As you don’t have to make any upfront
investment in the technology, you are only paying for the
service in short you are only paying for manpower thereby
saving a lot of capital which can be used for R & D
activity.
2) You don’t have to worry about breakdowns and heavy Annual
Maintenance contracts and frequent FDA updates on the
systems so it’s a big plus over there.
3) Outsourcing works on Pay as you go Basis so you are
paying only for actual submission you make in a year so if
you don’t plan any submission you don’t pay anything.
4) You won’t need to train or hire eCTD experts in your
company reducing your company’s permanent employees and
saving on HR expenditure. Companies with less than 10
submissions in a year will be the biggest beneficiary of
this model.
Now let’s focus on the negative side of Outsourcings
1) You lose control over timelines as you are
dependent upon your vendor for submission
2) Organization with huge volumes of submission will not
save much of money in this system
3) Data Security can be a Risk at given times but it can be
negotiated with CDA/NDA agreements with the clients, most of
the company even financial institutions do this for
outsourcing of their processes
So just to summarize companies with big volumes of submission should look to buy eCTD software and do all the hard work with training and implementation of systems and getting it 21CFR Part 11 Compliance, while companies with submission volumes as low as 10 or less should really opt for Outsourcing model as it saves tremendous amount of money and it helps you be at par with FDA requirement.
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- About the Company Perfect Pharmaceutical Consultants Pvt Ltd
- PPC has more than 30 years of Regulatory experience in Pharmaceutical field we can help you :
- a) Convert existing Paper Submission to eCTD
- b) File Annual report/ Amendment in eCTD format with US FDA , Health Canada , EU nations, and other eCTD Accepting countries.
- c) We write , compile and submit Drug Master file for US FDA and other countries
Contact US for any Query or an Obligation Free Quote - Enquire for eCTD Now
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