| Our esteemed clients
so far have been:
1. THQ INC, California:
We executed software development
projects on the SAP platform. Supported the Customer for SAP
functional consultancy. Due to our broadband connectivity
we were able to login to their development servers from our
office in Pune.
2. Johnson and Johnson Ltd, India:
We have developed successfully 21 CFR part 11 compliant QC
software for their Aurangabad
plant. This involved audit records, electronic signature (ESER)
concept as per USFDA guidelines. Our document and procedure
management system with GAMP guidelines successfully implemented
over last 3 years. This software manages SOPs, PS, QAPs and
its version management and provides a "controlled environment"
for managing critical documents.
3. Cipla Ltd, Mumbai Central &
Daund:
We have deployed our document and procedures management system
here which manages their inter-office memos and host of other
documents which supports this clients final objective of having
a paperless office environment. It has also aided them in
more efficient file retrievals; thus improving productivity.
Recently they have implemented Dossier Management Solution
of ours to manage electronic submissions to the western countries
and also to manage overall regulatory department's dossier documents
for different products.
4. IPCA Laboratories, Mumbai:
We have successfully installed dossier management solutions
to cater to their dossier submissions to USFDA. This software
solution handles electronic submissions to regulatory authorities
in Europe and USA such as DMF and ANDA submissions. And this
can be done for any country or trade bloc in the World. IPCA has successfully
done couple of "LIVE" DMFs to USFDA using our e-CTD solution.
5. JB Chemicals Ltd,Mumbai
We have deployed our Dossier Management solution to manage electronic
submissions to US and EU countries. This solution will be
primarily used for submitting ANDAs in e-CTD form to the USFDA
to start with. JB Chemicals have done successfully both LIVE DMF and ANDA e-CTD submissions
using our solution to USFDA.
6. Alkem Laboratories Ltd,Mumbai
We are in the process of deploying our Document Management System(DocsExecutive) to manage their SOP and other GMP related documents.
7. Zydus Cadila, Ahmedabad
We have installed our e-CTD solution Dossier-Mgmt for their regulatory department to manage their
e-CTD submissions to US and EU. Successful mock e-CTD ANDA with SPL was done by Zydus to USFDA.
"Live" ANDA submission is scheduled soon.
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