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Why integration is essential for outsourced regulatory submissions

Managing global regulatory submissions can feel like solving an enormous jigsaw puzzle under strict requirements and against the clock. Each puzzle piece must fit together perfectly. If the result is not compliant, the submission could be delayed or even rejected. Whilst these intricate challenges are not new, risks to success have accelerated over time. Increased competition is generating lightning-fast timelines in addition to heightened accuracy requirements.

Some organisations pass through these complexities with ease; however, many companies face repeated challenges and risks. Fragmented workflows, misaligned teams and rushed processes increase the likelihood of delays and rejection. The risks increase when the business model requires outsourcing of both regulatory affairs and translation responsibilities.

Greater efficiency is possible, and it is achieved through integration. In this article we outline why integration is essential when both regulatory and translation services are outsourced.

Why outsourcing has become a critical strategy

Outsourcing allows pharmaceutical sponsors of all sizes to leverage external expertise and infrastructure in a cost-effective way. It enables flexible scaling of operations, tactical allocation of resources and a more strategic focus on core business priorities. This approach also mitigates the risks associated with fluctuating demand, as sponsors can tap into specialised on-demand support tailored to their changing needs. Sponsors have successfully outsourced many aspects of clinical development for decades. However, if the selected outsourcing model is de-centralised and not closely linked with effective communication, the resulting inefficiencies and fragmented processes can lead to major problems.

Decentralisation risks fragmentation

A typical scenario where lack of regulatory and translation integration cause problems is during a global approval strategy. Imagine your team is preparing to launch regulatory filings in 30+ targeted countries and to manage this the regulatory affairs and language responsibilities are outsourced within a dual partner model: separate vendor partners for regulatory and language services, overseen independently by the sponsor.

Initially, everything is under control. The regulatory team focuses on the dossier’s progress, ensuring authoring and component handoffs are coordinated and aligned, while the language service providers (LSPs) handle the translations requirements. Late in the submission process the regulatory team is notified of a delay in the authoring of a critical and large component set.  This forces the team to quickly analyse the landscape, assess its impact, and determine a mitigation strategy. This process is made more challenging because of the existing outsourcing structure. Each LSP works in isolation, requiring multiple rounds of back-and-forth communication as well as tremendous effort to formalise and roll out a mitigation strategy. The sponsor is burdened with managing multiple providers leading to additional delays and mounting costs.

This scenario highlights the common challenges that arise when services are decentralised. When regulatory and translation services operate independently, and under varying and often competing brand names, inefficiencies multiply, miscommunications grow and administrative burdens skyrocket. Without an overarching integrated process, companies risk delays and threats to their global product launches.

How can you better manage these inefficiencies and risks?

When both regulatory affairs and translation responsibilities are handled externally, an integrated regulatory and translation delivery model is key to success. Combining regulatory expertise and language services under the roof of a single partnership transforms the process to achieve:

  • Strong collaboration from the start of the submission, leading to better alignment on expectations and timelines
  • Real-time management of timelines and priorities, without the need for additional oversight: Integration means no loss of momentum or delays in communication that easily compound when managing large dossiers with tight timelines
  • Fewer handoffs: By reducing the number of stakeholders involved, the risk of miscommunication and data inconsistencies decreases and sponsors avoid handoff-related delays
  • Concurrent processes: Regulatory submission preparation and localisation (e.g., translation of product information, labels and leaflets) can be done simultaneously, expediting timelines
  • Agile operations: Changes and updates are common in the iterative documentation process, and integration ensures regulatory and translation tracks are aligned with adjustments possible in real time
  • Audit-ready processes: Integrated service providers can implement standardised, traceable workflows across the board that simplify regulatory audits and inspections
  • Easier oversight: Eliminate oversight and management burden with streamlined workflow through a single point of contact. Integrated services deliver through a single source, avoiding the challenge of coordinating between multiple vendors, reducing inefficiencies and time delays
  • Centralised specialist expertise: Providers with both regulatory and language capabilities bring expertise in local regulations and cultural nuances, ensuring compliance in diverse markets.

The benefits of an integrated delivery model

One of the key advantages of an integrated delivery model is the ability to use resources that work within the same ecosystem. When regulatory affairs and translation experts collaborate within the same organisation, it fosters trust, flexibility, and efficiency that enable:

  • Open communication

    With all teams working within the same organisation, the communication loop is open. Sensitive information, product strategies and updates can be discussed openly without concerns about confidentiality or competition. Handoffs that slow down traditional set ups are minimised.

  • Seamless collaboration

    Regulatory and translation teams have access to the same systems, processes and tools, ensuring alignment at every stage of the submission process. They operate from a unified understanding of objectives, priorities and deadlines, effectively removing the barriers that typically hinder traditional setups.

  • Proactive problem solving

    Having regulatory and translation services delivered from the same organisation allows the team to proactively monitor and anticipate issues before they arise. If a dossier component is delayed, the regulatory team informs the translation team through designated contacts, allowing for immediate risk mitigation and problem-solving. 

  • Shared knowledge base

    Teams within the same company benefit from a collective and robust knowledge base. This includes sharing regulatory expertise, language nuances and cultural considerations. This knowledge-sharing ensures translations are accurate and fully aligned with the regulatory strategy.

  • Lowered administrative burden

    Clients are no longer burdened with managing multiple vendors or facilitating communications between separate entities. The integrated team takes care of everything, delivering a streamlined end-to-end service. 

A trusted partner from molecule to medicine

Managing a global submission does not have to be an uphill battle. By adopting ICON’s integrated regulatory and translation delivery model, companies can eliminate risks, ensure compliance, and accelerate their time to market. ICON’s integrated delivery model allows regulatory affairs and language services to be integrated and seamlessly delivered throughout the submission process, so all goals are achieved. Our experts’ industry knowledge, global experience and operational excellence positions us to help you achieve market success.

Powered by the healthcare intelligence of its teams, ICON’s end-to-end service offerings include regulatory experts dedicated to guiding global submissions from start to finish. Our Regulatory Affairs team has strong knowledge of complex international regulations and more than 35 years of experience managing submissions across multiple therapeutic areas. 

ICON Language Services is the industry’s largest life sciences language services provider. Our 2,700+ experts cover more than 300 languages, specialising in life science translations including regulatory clinical and commercial documentation. The team understands the critical nuances of translating life sciences content, ensuring submissions meet country-specific regulatory language requirements while safeguarding accuracy and compliance. 

Contact us to learn how we can integrate your regulatory submissions and translation requirements.

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