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HCL Technologies

Regulatory Affairs Capabilities

Regulatory Affairs Capabilities

Increasing regulations pertaining to drug filing/submission in the life sciences industry impedes companies to execute the process in a commercially-viable manner as well as focus on new product development. The industry’s growth is further challenged by patient deaths, dwindling pipelines, cost pressures of global regulators, and diminishing credibility of pharma companies.

Not only is obtaining approval for new drugs a challenge, but maintaining them in multiple markets is quite a task. This time consuming process of drug filing/submission leads to delayed launches, costing nearly a million dollars per day to the company. Several organizations have transitioned from paper submission to HCL’s electronic Common Technical Document (eCTD) format for faster authorization.

HCL’s outcome-based, service-oriented, experience-centric approach provides the right understanding of client objectives and enables the right training approach with relevant experience. HCL offers regulatory support for a plethora of services, facilitating a global delivery network and streamlined documentation practice with SOP conforming to global standards.