Navigating today’s regulatory publishing challenges: How life science companies are adapting

Regulatory publishing is no longer a straightforward administrative task. It requires collaboration with regulatory business units, precision, speed, and compliance. To improve the chance of positive health authority opinion and to reduce authority fees, companies are looking to their teams or partners to prepare submissions that are “right first time” – leaving little margin for error. 

Three major challenges dominate the landscape:  

• Escalating system costs: As companies expand, the demand on publishing technology grows. Licensing fees, system validation, IT support and training requirements increase, creating significant financial strain.  
• Rising resource costs: A growing product portfolio requires more staff to manage lifecycle maintenance. This not only drives up personnel costs but also adds pressure on associated functions such as IT, HR, and finance.
• Scalability limitations: In-house teams often struggle to keep pace with expanding global authorizations. As submissions multiply across regions, bottlenecks can emerge – threatening timelines and compliance.  

Global health authorities operate on strict timelines, and delays can have profound consequences. Missing a submission window may postpone product launches, impact patient access and erode competitive advantage.  

Companies must respond with agility to evolving requirements, such as new electronic submission formats, metadata standards or region-specific mandates. The ability to adapt is key for survival in a competitive market. To take advantage of new guidelines and formats, companies can tap into the expertise offered by partners to efficiently navigate complexities and be prepared to implement these when they become mandatory.

Scalability is perhaps the most underestimated challenge in regulatory publishing. A company may manage submissions effectively during quieter periods, but sudden spikes — such as simultaneous launches across multiple markets — can easily overwhelm internal teams. Conversely, during quieter phases, maintaining a large publishing staff can be inefficient and costly. The inability to flex resources up and down creates both financial and operational strain.  

To address these challenges, many life science companies are turning to specialized outsourcing models. Outsourcing regulatory publishing does not mean relinquishing strategic control; rather, it allows organizations to focus on higher-value activities such as regulatory strategy, market expansion, and innovation.  

Key benefits of outsourced support include:  

• Cost efficiency: Technology-progressive outsourcing providers can include publishing tools, validation platforms and document formatting systems as part of their service. This eliminates the need for companies to invest heavily in their own licenses and IT support.
• Access to expertise: External teams bring subject matter experts (SMEs) with experience across submission types and regions. This ensures compliance with diverse health authority requirements.  
• Scalability: Outsourcing partners offer more agility to scale resources during peak workloads and quieter periods. Freeing regulatory teams from routine work allows internal staff to focus on strategic tasks and innovation – providing flexibility without long-term overhead.  

Not all companies outsource end-to-end regulatory operations. Many adopt hybrid models, retaining in-house control over authoring, review, and approval while outsourcing publishing activities.

This approach allows organizations to maintain strategic oversight while leveraging external expertise for operational execution. Outsourcing partners can work directly with document contributors and submission managers to ensure dossiers are submission-ready, validated, and dispatched on time. Regardless of the outsourcing model chosen, quality and compliance remain non-negotiable. Robust quality control processes are essential to ensure that every submission meets regulatory standards.

Experienced outsourcing partners implement multi-layered QC checks, metadata management, and validation protocols. These measures reduce the risk of errors and support the goal of  “right first time,” helping to protect companies from costly delays or rejections.

By outsourcing operational publishing support, life science companies can redirect resources to areas that drive growth and innovation. Regulatory strategy, market expansion, and product development can all benefit from increased focus when operational burdens are lifted. This strategic reallocation of resources helps organizations to remain competitive while maintaining compliance.  

Looking ahead, regulatory publishing will continue to evolve alongside digital transformation. In the near term, artificial intelligence, automation and advanced analytics are poised to reshape dossier compilation, validation, and dispatch.  

Life science companies that embrace flexible, scalable models will be best positioned to navigate this future. Whether through full outsourcing, hybrid approaches or advanced technology adoption, the goal for life science companies remains the same: ensuring timely, compliant submissions that bring therapies to patients faster.

Regulatory publishing is a mission-critical function in the pharmaceutical industry. Rising costs, resource pressures and scalability challenges demand innovative solutions. By leveraging external expertise, adopting hybrid models and investing in robust systems, companies are overcoming these hurdles.  

The path forward lies in balancing control with flexibility, ensuring compliance while enabling growth. With this strategy, life science organizations can focus on what matters most — delivering life-changing therapies to patients worldwide.