Solusoft Technologies Pvt Ltd

Dear Sir,





We have been working for the pharma companies from past 10 Years. We know what all are the process need when a pharma company is * a single day's delay in getting a product to market can result in the loss of millions of dollars of potential profits.SoluSoft Pharma R&D document

Management software system is a utopian solution that integrates advanced document control and management with a training component to create an

Unparalleled system specifically preconfigured for pharmaceutical companies' document and project management needs with 21 CFR Compliance.



We have developed and application for every department of pharma companies to Create, Save, Delete, Edit and Keep Audit Trail.



Some Features:



API (Active Pharmaceutical Ingredie ...nt):-Dealing with drug master file management (regulated, applicant) and submission, CEP certificate distribution and upgrade.

*Create DMF

*Create Product

*Create CEP Certificate

*Create CD

*Check List

*History

*Product Change Summary Form

*Freeze

*Approve

*Reports



Regulatory Department: - Dossier Management and submission to regulated and branded markets. Integration to the eCTD (Electronic Common Technical Document) software.

*Create Dossier

*Search Dossier or Product

*Create Product

*Variation Management

*Checklist

*History

*Edit or Copy Dossier

*eCTD Specification / Guideline

- Software solution for eCTD ICH / US / EU / CA

- Incorporates ICH e-CTD specifications version 3.2 for M2-M5.

- Regional US version 2.01 for M1 modules.

Regional EU version 1.3/1.4 specifications covering NP/MRP/DCP/CP categories.

- Regional CA Version 1.0 specifications for Canadian Submissions.

- Study Tagging File STF

- STF Specification Document Version 2.6.1.

- ICH-stf-v2-2.dtd. ICH-stf-stylesheet-2-2a.xml.

- Latest Valid-Values.xml

Guidance for Industry Regulatory Submissions in Electronic Forma Drug Establishment Registration & Drug Listing.

- SPL Implementation Guide for FDA Drug Establishment Registration & Drug Listing V1.0





CQA Department:- Technical analytical document management and sharing latest versions across remote locations.



Shipping Department:-Docket/invoice and license management



Marketing Department (Artwork Management):-Brand Management, Artwork Management (Process Involves marketing, Regulatory, PPC, PDC, CQA Departments)



Let me introduce us. We Solusoft Technologies Pvt Ltd & Solusoft Inc are India as Well USA based designing & Development firm we have experience of more than 17+years with 190+ Technical Team. We have worked with many Pharma Companies. Recently we worked for NYCOMED and working on different projects like Human Resource Management, Scan FP, Cam FP, and Online paper Testing Modules as Well IPCA lab. We have done many projects from USA/UK/INDIA



Our Recent Clients:

IPCA Lab, Mumbai

Nycomed,



For more information on our Products, please visit: /product.html

For more information on our Global 360 practice, please visit: /Partners.html

For more information on our Microsoft Sharepoint practice: /Microsoft_SharePoint.html



Power Point Presentation is attached with this email of the application which we developed for IPCA LAB.



Kindly review and let us give an opportunity to meet and discuss this product in detail as well show you demo.

This would result in High Quality, Strong Dossier Management, and Marketing Management As well Regulatory Management. Read more