Since the establishment of the United States’ FDA in 1906, national regulatory authorities around the globe have followed example and put in place standards to guarantee the safety of patients and citizens. Each different country, or region as is the case with the European Union’s (EU’s) European Medicines Agency (EMA), has differing regulatory requirements that must be met to bring products to market and maintain their viability. As a result, regulatory requirements shape and move pharmaceutical products and medical devices through their lifecycle. 
 
The complexity of strict regulatory requirements and how they differ between countries, as well as the vast amount of preparation that must occur to formulate and file regulatory submissions on time, necessitate the cohesive management of the regulatory lifecycle of pharmaceutical and medical products. Life science organizations that want to maximize the impact, safety and revenue of their new and existing products must proactively make regulatory affairs part of their lifecycle planning strategy. 
 
The Critical Importance of Regulatory Lifecycle Planning
Regulatory agencies are the gatekeepers of the pharmaceutical market. Critical milestones in a life science product’s journey are mandated, evaluated and approved or rejected by government regulators. As such, it’s only logical to take regulatory strategies into consideration from the very beginning of a product’s lifecycle journey. Life science companies can optimize value once products hit the market, reduce risk of regulatory rejection or unexpected obstacles to regulatory approval, and gain greater control over costs associated with filings by building regulatory lifecycle management into initial product development planning. 
 
Unplanned approaches to regulatory affairs can create unexpected delays in approvals and, therefore, go-to-market timelines, which can potentially impact the long-term revenue of pharmaceutical products and medical devices – especially if a competitor’s product is first to market because of a regulatory rejection. The challenge of managing regulatory affairs throughout a product’s lifecycle can be overcome if companies address their regulatory strategy in the product development phase. 
 
Current Operating Model Challenges for Regulatory Management
Bringing new and innovative medicines to market is a complex task that involves the significant investment of resources. When one considers the variables of increasing regulatory complexity and differing requirements across geographic regions from their respective regulatory agencies, it becomes apparent that life science companies have many obstacles to overcome. Many product sponsors are also simultaneously handling regulatory filings for expansions of approved drugs to new markets and launches of rebranded products that can treat multiple conditions in addition to brand new offerings. Balancing the management of these concurrent regulatory requirements and processes can be extremely difficult for life science companies – especially smaller organizations that lack the human resources and budgets to leverage workers and technology solutions to solve the problem. 
 
Compounding the issue of diverse and complex regulatory requirements across geographic regions, regulatory authorities are beginning to embrace digital solutions that life science companies rely on for regulatory filings. As a result, health authorities expect more complex submissions with additional data to support outcomes and safety indications – supported by the use of digital technologies such as cloud, artificial intelligence (AI), and natural language processing (NLP). As regional regulatory demands become more complex and data-reliant, managing regulatory activities for global operations increasingly requires a depth of expertise and local knowledge of regulatory requirements. 
 
Implementing a Regulatory Lifecycle Management Strategy
To overcome the daunting obstacles of planning and managing regulatory activities throughout a medical device or pharmaceutical product’s lifecycle, life science organizations and teams responsible for regulatory processes should adopt a regulatory lifecycle management strategy. This strategy provides teams with a more robust end-to-end oversight of the entire regulatory journey a product experiences throughout its lifecycle. 
 
By engaging in this strategy, organizations can view their product research and development, as well as market decisions, through the lens of regulatory affairs. Possessing a long-term perspective on the regulatory journey allows companies and researchers to capture the necessary data to meet modern regulatory requirements around the world. Ultimately, this approach results in timely compliance and helps organizations avoid excessive cost expenses during product launches, while avoiding renewal delays that can reduce the potential revenue of a product throughout its lifecycle. 
 
Optimizing Commercialization Through Regulatory Lifecycle Planning
The way that organizations optimize regulatory strategies to maximize the value of a medicine will differ depending on the needs and goals of the specific product and its sponsor. Regardless of how life science companies tackle the problem of complex regulatory requirements, it will always require significant planning in conjunction with constantly evolving clinical research to support label expansions and the launch of new products. Life science companies will find that, when these efforts occur concurrently, they are in a better position to maximize performance and value throughout the product lifecycle by ensuring optimal commercialization of new and existing brands. 
 
Keeping track of everything can be heavy lift: all the detailed planning and tedious tracking of lifecycle management (LCM) across relevant geographies is essential to ensuring the full value of your products, helping you avoid duplicate activities, reduce non-compliance risk and efficiently manage your regulatory experts’ time.