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November 26, 2020

Life sciences organizations in their role as global manufacturers and suppliers of medicinal products are required to work in highly complex and hybrid scenarios to meet regional regulations. In addition, the life sciences landscape is witnessing an increased number of mergers and acquisitions when compared to any other industry. To stay competitive in the fast, volatile and complex business environment while complying to the regional regulations, life sciences organizations end up working in fragmented, ad hoc ways in each region, thereby denting their own operational efficiency.

On one side of the spectrum, regulatory health agencies such as US Food and Drug Administration (FDA) are working towards international regulatory harmonization to tackle the increased complexity resulting due to global scale of life science industry operations. This is manifested through their involvement in diverse international organizations including the International Council for Harmonization (ICH), International Pharmaceutical Regulators Programme (IPRP), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), Asia-Pacific Economic Cooperation (APEC) and International Coalition of Medicines Regulatory Authorities (ICMRA). On the other side, life sciences industry is striving to identify potential areas across the regulatory operations value chain that can be centralized and harmonized to achieve regulatory compliance in a cost-effective manner.

Let us now take a look at some of the common challenges faced by life sciences organizations in their global regulatory operations.

Lack of a singular process design/ workflow

One of the biggest regulatory operations challenges is to contend with multiple process designs based on the various roles involved in a specific process for specific region resulting in disconnected designs.

Multiple hand offs and bottlenecks

Disconnected designs result in multiple hand offs and act as bottlenecks for seamless workflow. This has an impact on timeline, delaying critical and time-sensitive submissions to the health authorities.

No process documentation

Detailed comprehensive documentation is the backbone of any successful submission process. In regulatory operations, documentation such as standard operating procedures (SOPs) and training documents can influence learning timelines and complexities. Absence of accurate documentation can lead to a steep learning curve.

High dependency on people

Due to disconnected designs and lack of comprehensive process documentation, the entire regulatory operations approach is always dependent on a few, highly skilled and talented people. During peak workload and in situations such as business continuity, high dependency on limited resources severely constrains and delays timely submissions to health authorities.

Business Process Transformation can be the solution
In order to avoid such scenarios, Business Process Transformation for Global Regulatory Operations is the need of the hour. Process transformation could be achieved by bringing process harmonization leveraging in-depth domain expertise, regulatory knowledge of industry best practices coupled with process mapping, and by applying lean principles and automation. The output of process harmonization is the development of standardized process designs and comprehensive documentation for regulatory processes including process SOPs and operational procedural instructions to achieve targeted business benefits. It is, however, necessary for any such transformation initiatives to ensure a harmonious acceptance of the new standardized processes from all stakeholders. This requires a vigilant and meticulous approach for implementation of process harmonization in regulatory operations of pharmaceutical industry. Once implemented, the benefits of such Business Process Transformations can transform the conduct of regulatory operations markedly.

Key Benefits of Business Process Transformation

  • Standardized processes that are industry benchmarked - Implements ‘One company One standard process’ across the globe to overcome disconnected processes and ad hoc ways of working for each region.

  • Common documentation across globe - Common training SOPs and work instructions for each work stream helps to follow a single source of truth.

  • Reduction in learning curve - Following detailed operational procedural instruction manuals reduces the dependency on in-person training to a considerable extent, enabling faster learning, thereby resulting in reduction of learning time. Appreciable reduction in learning curve is possible with deployment of successful standardized process designs and related comprehensive documentation.

  • Efficiency gain/ cost reduction - All the above benefits funnel down to efficiency gain and reduction in cost. Successful implementation of process harmonization can effect substantial efficiency gain.

It is imperative to shed off the siloed and localized approach of working and bring about business transformation in global regulatory operations by centralizing and harmonizing process with standardized and simplified procedures and documentation. Further, these clean processes are pre-requisites for automating workflow management, tracking, reporting, digitalization of quality checks and KPI monitoring.

Anita Bachal is working with the ADD Regulatory and Regulatory affairs services team as a Domain Consultant. She is a microbiologist with a masters’ degree in science. Anita possesses over 22 years of work experience in global regulatory affairs with 14 years of experience in strategy, chemistry, manufacturing and controls (CMC) and regulatory operations for biotech products and vaccines. She is six sigma green belt certified for her contribution in regulatory process enhancements through creation of lean processes; regulatory bench marking; use of automation and best practices.


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