We Do What We Say

Pharmaceuticals

In recent years, product safety and pharmacological risk management has risen dramatically in both importance and visibility driven by a growing interest among regulators, consumers and the medical community.

In order to meet the increasingly complex and diverse global regulatory requirements, GSTi has a comprehensive suite of integrated software solutions strategy that enable all Life Sciences organizations, regardless of status or size, to implement effective domestic and global pharmacological risk management programs.

The Life Sciences and Pharmaceutical industries are constantly evolving and, perhaps, the most highly regulated in the world. Regulatory authorities are unifying their submissions structures to improve the collection, scrutiny, and storage of data. Pharmaceutical documentation initiatives such as SPL/PIM, eCTD, ICH M5 and EVMPD are compelling companies to implement systems to maintain compliance. These systems also need to keep up-to-date the information about the derivations of each pharmaceutical product, as it is marketed, maintained, and actively enhanced through its life cycle.

To ensure life sciences and pharmaceutical regulatory compliance on a global basis, GSTi is developing regulatory information software that integrates compliance with business processes and regulatory activities. Supporting all major regulatory initiatives, including the EVPMD, we provide exceptionally versatile software that supports registration tracking, registration updates, questions, or commitments, and change request management.

GSTi builds additional capabilities on business analytics using Cognos, PV.Analytics etc.

Staff Augmentation on Pharma

Pharmacovigilance
GSTI provides technical expertise to fill gaps in client’s immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labour as a variable cost.
GSTi provides staffing solutions on various reporting skillsets viz:

Designation Software Engineers Business Analysts Technical Architect Project Managers
Experience 7-8 years 5-6 years 8-15 Years 15-20 years
Certifications Oracle Argus 7.0 Standard Edition Implementation FAHM (Fellow, Academy for Healthcare Management) and CDHP certified
Skillsets Argus Safety 5.x/6.x/7.x Single and Multi-tenant Database Requirements gathering, test case preparation, Business Flow Diagrams, Business Scenario preparation, Business process re-engineering, implementation , User Training, MS Visio WCF, LINQ, Entity Framework, WEBAPI, ASP .NET MVC, ASMX, TPL, SOA, SOAP, REST, IBM MQ Series, MSMQ, SSIS, NServiceBUS, Oracle ESB TSO/ISPF,INFOMAN,JBUILDER,VISUAL SOURCE SAFE,CICS, VSAM, Project Management, Business Process re-engineering, MS Project, PPT
Designation Software Engineers Business Analysts Technical Architect Project Managers
Experience 7-8 years 5-6 years 8-9 Years 15-20 years
Skillsets Expertise in GCP, GPPv, ICH/CFR and GMP regulatory guidelines, Audits and Documentation, Cognos 7.x, ReportNet, Cognos 8.x, Cognos 10, Business Objects, OBIEE, Erwin, Cognos Framework Manager Requirements gathering, test case preparation, Business Flow Diagrams, Business Scenario preparation, Business process re-engineering, implementation , User Training, MS Visio .net framework 2.0/3.0/3.5/4.0, C#, Asp.net, WCF, MVC 3.0/4.0, Ajax, JQuery,Visual Studio 2003/2005/2008/2010, VB6.0, ASP, FXCOP, Perfmon, SQL Profiler, .Net Profiler Cognos 7.x, ReportNet, Cognos 8.x, Cognos 10, Business Objects, OBIEE, Cognos 7.x, ReportNet, Cognos 8.x, Cognos 10, Business Objects, OBIEE, Project Management, Business Process re-engineering, MS Project, PPT
Designation Software Engineers Business Analysts Technical Architect Project Managers
Experience 7-8 years 5-6 years 8-9 Years 15-20 years
Certifications Certified Tester Foundation Level (C.T.F.L) Project Management Professional (PMP Certified).
Skillsets Emprica Signal, Emprica Trace, Life Science Data Hub 2.1.3/2.2, Oracle Clinical 4.5.3/4.6/5.0, Oracle Remote Data Capture 4.5.3/4.6/5.0, Thesaurus Management System 4.6 and Oracle Inform 5.5, Toad (database tool used for oracle DB), SQL Developer Requirements gathering, test case preparation, Business Flow Diagrams, Business Scenario preparation, Business process re-engineering, implementation , User Training, MS Visio .net framework 2.0/3.0/3.5/4.0, C#, Asp.net, WCF, MVC 3.0/4.0, Ajax, JQuery,Visual Studio 2003/2005/2008/2010, VB6.0, ASP, FXCOP, Perfmon, SQL Profiler, .Net Profiler JDBC, JBuilder, Java Beans, Java Servelts, MS-Office 2000, MQ Series, Xpediter, Smart Test, APS, APC, FileAid, Abend-Aid, Easytrieve Plus, Dumpmaster, Endevor, QMF, CICS, VSAM, Jobscan, TSO, ISPF/PDF, MAX/VSAM Editor, IEBGENER, SyncSort, SPUFI, DCLGEN, OWL, Brownstone Data Dictionary
Designation Software Engineers Business Analysts Technical Architect Project Managers
Experience 7-8 years 5-6 years 8-9 Years 10-15 years
Skillsets Spotfire Statistics, Predictive, content, location and event Analytics,Teradata, Oracle, and SQL Server. Requirements gathering, test case preparation, Business Flow Diagrams, Business Scenario preparation, Business process re-engineering, implementation , User Training, MS Visio .net framework 2.0/3.0/3.5/4.0, C#, Asp.net, WCF, MVC 3.0/4.0, Ajax, JQuery,Visual Studio 2003/2005/2008/2010, VB6.0, ASP, FXCOP, Perfmon, SQL Profiler, .Net Profiler SIX SIGMA Y.B., US Healthcare IT, RCM, EMR, PMS, HL7 Standards, Meaningful Use Stage 1 & Stage 2, CMS incentive Programs, PQRS, eRx, NCQA’s PCMH, PGIP

To view our Resource Augmentation procedures, Click Here