Innovative Regulatory Outsourcing Model from Navitas, to Change Pharmaceutical Sector Forever
PRINCETON, N.J.: Pharmaceutical is an extraordinarily profitable business. But past few years have shown signs of continuous downshift with complex global regulatory requirements and increasing cost pressures on regulatory functions. These reasons attribute to the adoption of innovative technology solutions by companies, as a result of which Navitas, a global education provider has introduced an innovative regulatory process outsourcing model to address potential ways to meet the cost, capability and capacity challenges.
The program integrates industry insights from its Nets in the regulatory domain and its Technology capabilities and partnerships, into a unique and innovative suite of process outsourcing services for Life Science companies under the banner 'Process Outsourcing enhanced by Technology.'
Navitas suite of Regulatory Services includes: Submissions and Report Publishing, License Maintenance for marketed products, Labeling and Artwork Services, Regulatory Information Management and Regulatory Strategy and Support. Navitas also provides invaluable subject matter expertise in evolving electronic submissions standards and health authority specific guidelines and processes.
The company facilitates web-based electronic Document Management and eSubmission software with ease of installation, ease of use, regulatory compliance and affordability as its primary features- all through its portfolio of software pharmaReady.
"The challenges faced by our clients in the pharmaceutical industry in light of increasing and more complex regulatory requirements can only be addressed by innovative solutions. In integrating our process outsourcing and technology capabilities, we have created a suite of services which are unique in this sector" says Shalabh Kumar, Navitas' Global head of Services.
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