The life sciences industry faces unprecedented challenges in responding to an increasingly complex regulatory environment characterised by a faster pace of regulatory changes, shorter product life cycles, and an evolving set of global laws and regulations.
At the same time, global life sciences supply chains are being stretched by a variety of internal factors and external influences. Failures of any kind in the supply chain can result in significant loss of revenue from delayed product launches.
In a complex, ever-shifting environment like this, a safe, transparent and reliable supply chain is critical in managing global compliance.
But where does the localisation supply chain fit into global compliance? How can a partnership with your localisation service provider help you to manage regulatory compliance more efficiently? What does good localisation look like?
In this blog, we explore the challenges around identifying, analysing and mitigating regulatory compliance risks in the localisation service process, in partnership with your service provider.
Identifying Compliance Risks: Quality at Speed, in Volume
Over the past years, life sciences companies have seen significant growth in the development of new product types with shorter lifecycles.
Covid-19 vaccines have broken the bank, of course, in the speed of regulatory implementation and time-to-market. But already two decades ago, researchers identified the need to drive rapidly to ‘killer’ experiments that provide decision-critical information, focus limited resources to enhance speed, break down barriers between research and manufacturing, and manage product life cycles effectively, in the landmark development of Celebrex®, a highly successful medicine for arthritis.
Complying with legislation and implementing changes at an increasing pace requires for the entire supply chain to work in a coordinated, transparent and timely manner.
In the localisation supply chain, the greatest risks to regulatory compliance arise firstly from the need to translate large volumes of data for the marketing authorisation application (MAA) at maximum accuracy, within a restricted timeline, and secondly from managing the subsequent frequent regulatory changes requiring further translation – whilst maintaining the same level of high quality and speed.
Another regulatory compliance risk centres around the challenge of managing compliance throughout the supply chain, including oversight of the localisation service provider’s workflows and processes.
Analysing Compliance Risks: What’s at Stake?
Preparing an MAA for a regulatory authority like the European Medicines Agency is even at its best a lengthy, involved process. Working with the regulatory authorities of another country adds a further layer of complexity, with applications required in the local language.
In your MAA documentation, whether it’s the clinical trial summaries, instructions for use, or technical sheets, issues in document formatting or the accuracy and terminology of the translation may lead to significant delays in the application and approval stages, or in a worst-case scenario to the regulatory authority declining the application.
At the same time, efforts to maintain a very high quality of translation cannot compromise application submission timelines. For a first application, the volume of data for translation is significant, and unless the localisation process is built to accommodate it, delays in producing the translation can lead to just as severe consequences as issues within the translation itself.
Further down the line, the increasingly frequent regulatory changes also require for the localisation workflow to accommodate quick, efficient turnarounds, to ensure that the product’s validity is not compromised in any of the markets it’s available in.
Mitigating Compliance Risks: What Good Localisation Looks Like
Mitigating the above compliance risks in the localisation supply chain involves close communication and dialogue with your localisation service provider.
A good localisation service provider understands the challenges of the regulatory process, and your need for not just high translation quality, at speed, in volume, but for transparency, compliance and flexibility.
This converts to concrete actions and processes. Quality is everyone’s responsibility.
At your localisation service provider, this means that:
- Account Managers understand the challenges of the marketing authorisation application process.
- Project management workflows are agile but robust.
- Translation quality management processes comply with industry standards.
- Translators are vetted, tested subject matter experts.
- Translation teams are sufficiently large to handle volume data at speed.
- Translation consistency and terminology is managed through sophisticated language technology solutions.
- Documentation is double-checked and formatted correctly at delivery.
- Deliveries are correct, timely and complete.
At the Heart of it All: Patient Safety and Products That Deliver
Localisation is an integral part of life sciences supply chains today. It is an enabler of global regulatory compliance. As such, identifying, analysing and managing risks around the localisation supply chain helps you to ensure that the localisation cog does not fail.
Good localisation starts with partnering with a localisation service provider who understands the challenges of the global regulatory process, and offers not just quality, at speed, in volume, but transparency, compliance and flexibility.
The purpose of the localisation supply chain in the global regulatory process is to deliver correct, high-quality translations, submitted to the regulatory authority on time. At the end of the day, regulators, life sciences companies and their suppliers share the same passion – patient safety and products that deliver.