Staying on track with regulations: How manufacturers build resilience in complex markets

Regulatory resilience is becoming key to international operational capability. Using a fictional example, this article shows how manufacturers can identify regulatory bottlenecks and make effective use of digital solutions such as RIMS. The result: structured processes, an optimal overview, and a clear path out of regulatory complexity.

"We can no longer keep track of everything at once," thinks Thorsten Willmer, Head of Regulatory Affairs, as he stares at the sales plan for the coming year. MDR, IVDR, UKCA, CH-REP, new FDA requirements: the demands are piling up, and regulations are changing faster than ever. It used to be more manageable. But today? Processes are more complex, teams are overloaded, and the pressure to be compliant everywhere at once is constantly increasing.

Resilience as a strategic goal

Many consider regulatory requirements to be a hindrance. But they can become a strategic lever if companies build regulatory resilience: the ability to remain operationally effective and market-ready even under regulatory change.

Regulatory resilience describes an organization’s ability to maintain operational stability despite continuously changing regulatory requirements. A resilient company can adapt quickly and proactively to new requirements and ensure long-term compliance. It anticipates trends early on and minimizes dependencies.

The goal of regulatory resilience is to ensure continuous market access across all relevant target markets. Regulation thus becomes a strategic success factor rather than an obstacle. It is not about saving money by doing without, but about designing regulatory processes and workflows effectively and efficiently.

Analysis of bottlenecks: Where is the problem?

Thorsten talks to his team and identifies four key weaknesses:

• Overview of global requirements: It takes a lot of effort to keep track of developments and changes in all relevant regulations worldwide. As a result, his employees are often surprised by changed or new requirements. This causes friction in otherwise well-planned processes.
• Document access and versioning: Searching for documents and checking the correct version statuses takes a lot of time. In addition, the references in the documents are prone to errors.
• Knowledge sharing and control: Work on a product file is usually distributed among many people. Because the information cannot be passed on in the documents and the filing structure, it must be actively exchanged. This also increases the likelihood of errors and costs time.
• Resource allocation: The workload shifts from one team to another: sometimes the biological safety specialists are overwhelmed, sometimes the post-market team lacks resources. And because of the high level of specialization, team members cannot switch between topics without restrictions.

How can these bottlenecks be alleviated? And how can a system be created that combines transparency, flexibility, and efficiency?

RIMS for technical documentation

A key lever for this is the digitization of technical documentation, for example through the use of RIMS (Regulatory Information Management Systems). A RIMS stores content as small units of information ("knowledge units") instead of traditional documents. These units are automatically compiled into a document as needed. This means that each piece of information only has to be maintained once, even if it is used multiple times.

A typical example: In traditional document structures, the product description that appears in the user manual, label, and risk report is maintained multiple times. In RIMS, on the other hand, this information is created as a single "knowledge unit" and managed centrally. If the description changes, for example after a design update, it is adjusted once and is immediately available correctly in all affected documents.

This saves time, reduces redundancies, and simplifies maintenance—even for product variants or changes. The international benefits are particularly significant: content can be combined according to market requirements, while master data is maintained centrally. This prevents inconsistencies between the EU, UK, FDA, or TGA.

At the same time, the internal coordination effort is reduced: changes are transparent, responsibilities are clearly distributed, and approvals can be controlled in a targeted manner.

Simplify collaboration with external partners

Cooperation with external partners is also made much easier with a RIMS. Instead of laborious document collection, service providers are given targeted access to the relevant content and can work directly in it.

A concrete example: Previously, Thorsten's employees had to send complete documents to translation agencies or authorized representatives, including version control, conversion, shipping, and return. Today, external partners access the necessary content directly via a secure platform, for example, only the IFU or CH-REP-relevant product data. Tasks, deadlines, and changes are clearly visible. This saves queries, speeds up processing, and increases data security.

This is particularly advantageous for international projects: CH-REP, UKRP, translation agencies, or external auditors access structured data via password-protected areas. The internal team maintains an overview, saves time, and still remains in the lead.

Additional digital solutions

Thorsten comes across additional tools that efficiently support specific regulatory tasks. These include:

• Literature research tools for clinical evaluation and post-market surveillance
• Risk management solutions for structured risk assessment
• Regulatory intelligence tools that automatically analyze and prioritize requirements in target markets

What regulatory intelligence tools actually do: They help filter requirements by country, e.g., by product type, risk class, or market access requirements. Some solutions automatically suggest relevant target markets based on existing approvals or similar products. This is particularly helpful for business development when regulatory feasibility needs to be factored into new market decisions.

These systems can be integrated into existing platforms via API interfaces. This creates a digital ecosystem that interlinks processes – ideal for internationally active companies.

Outlook: Step by step toward the goal

The path to regulatory resilience is not a sure-fire success, but it is feasible. Thorsten Willmer wins his team over to a structured restructuring of processes. One step at a time, with a realistic schedule and targeted tool support. And even the skeptics are beginning to realize that the effort is worth it.

Many manufacturers reach this point with similar questions:

• Where should we start – with organizational structures, regulatory processes, or digital systems?
• Which regulatory workflows can realistically be digitalized without adding complexity?
• And how do we ensure that digital solutions are not only technically sound, but also regulatory robust and operationally effective?

This is where Metecon provides targeted support. Through strategic consulting, we help organizations embed regulatory requirements into roles, decision-making structures and processes. Building on this foundation, we support the digitalization of regulatory workflows – from system selection and implementation to regulatory-sound, day-to-day use. The objective is not a collection of tools, but a coherent interaction between organization, processes and digital solutions.

If you want to build regulatory resilience deliberately rather than reactively, a conversation is a logical next step.

Let's discuss how to build regulatory resilience through structured and digital regulatory workflows.