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Regulatory Affairs and Quality Assurance Graduate Program of Temple University School of Pharmacy


 4C Pharma www.4cpharma.com

A New Jersey based healthcare solutions provider and an Oracle partner that has been named in the top 10 CROs in the Pharma & Biotech Industry, in the past, by Pharma IQ. 4C Pharma is one of the fastest growing service provider organizations within the Pharmacovigilance field. Additionally, they offer services in Regulatory Affairs, Medical Writing, Safety Software Hosting, and Medical Information Call Center. 4C, from the time of its inception, has always focused on the quality of service that is delivered, along with a cost effective alternative solution to fit every budget.  This customizable solution makes the process seamless for any company or educational entity. 4C Pharma is ISO 9001:2015 and ISO 27001:2013 certified, with a fully validated and integrated Oracle Argus Safety system installed in-house. This allows pharmaceutical companies to focus on R&D and other departmental tasks without extensive technology overheads in deployment, maintenance, and support.  They become an extension of the partner they work with.  With their Oracle Relational Database Management System and multi-tenancy, multiple clients can use Argus with customized workflow, secure role based access, and control over the data.


          Their global presence stretches from the U.S. to Canada and further to the Middle East, Europe, Asia, Africa, and Australia. They have an exemplary team of health care professionals, well-established facilities, and processes capable of providing robust support in Regulatory Submissions, Medical Writing, Medical Information Call Center, Literature Search, Case Processing, Signal Detection, Aggregate Reporting, Pharmacovigilance set up and training on software applications such as Argus. The 4C team has expertise on multiple safety and regulatory applications like ARISg, CARES, SCEPTRE, ClinTrace, eXtedo, Register, Lorenz etc. resulting in shortened transition time and effort for the projects to go live.


            Being founded and managed by medical doctors, they truly exemplify how seriously to take Drug Safety and how to best implement the regulatory and industry practices while staying cognizant of the needs of their partners.  They stand behind their motto, “Your Responsibility, Our Passion!”

 

 

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