By Chitra Lele and Bindu Narang, Sciformix Corporation
A global business model to ensure compliance and accuracy in an increasingly complex environment
The global pharma industry is exploring new growth opportunities in emerging markets, strengthening R&D by collaborating with industry and academic partners, moving towards a mixed portfolio of innovative and generic products and focusing on operational efficiency. As a result, even the marketing of these products is being driven more by partnerships between multiple companies. There has been a substantial increase in the number of licensing and supply partnerships between generics manufacturers based in emerging markets and large or mid-sized global pharmaceutical companies.
This global expansion across different geographies has led to decentralization that can, in many cases, slow down complex processes and reduce operational efficiency and profitability, while delaying time-to-market. Furthermore, the need for greater quality checks to ensure brand integrity is paramount in the global marketplace in order to comply with local regulatory mandates and to manage the resources that are spread across multiple geographies.
By outsourcing global labeling operations to specialized vendors, innovators and generic manufacturers are able to access managed services spanning Commercialization to Adverse Event Labeling processes (CAEL). Vendors that implement innovative tools and LEAN processes address the aforementioned labeling challenges by providing automated text comparison, content management, and workflow management. Automation reduces human intervention and ensures the development of high quality deliverables that significantly reduce overall operational costs and improve the time-to-market across organizational product lines.