Regulatory Affairs

Life sciences is a highly regulated industry, full of sensitive information that is required to be maintained efficiently. Documents are the backbone of any life sciences segment since it establishes the quality of processes and assurance of safety. The growing volume of documents in organizations exponentially increases the demand to replace traditional and manual documentation practices to reduce time, effort, and errors. In such scenarios, the absence of a proper Document Management System (DMS) increases the chance of misplacing critical documents and tracking changes significantly.

As many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key measures to submit documents in the electronic format to remain compliant. 

The eCTD publishing and submission is a cumbersome process that requires the cooperation of multiple individuals from various departments within the organization. Also, it is paramount that Standard Operating Procedures (SOPs) and clear expectations are established to streamline the process, which requires ample time and proper planning.

On-time Regulatory submission is the key to achieve quick time-to-market. But, with a lack of planning, the industry could face a lot of complications which may result in rejected submissions, delayed market-entry, increased costs due to extended timelines. Hence, it is necessary to develop a concrete submission plan and identify where technology can help improve Regulatory submissions. 

Under the Classification, Labeling and Packaging of substances and mixtures (CLP) regulation, Chemical companies, who wish to place hazardous chemical mixtures such as paints, coatings, detergents, solvents, etc. in the European market are required to provide notifications of the hazards in their products. Poison centres take the responsibility to collect relevant information about hazardous mixtures and provide medical advice during health emergencies. 

Drug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material. The entire process involves near-constant correspondence between Regulatory affairs departments and the global Health Authorities (HAs).

The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.