Hardly any industry is under as much regulatory pressure as the chemical and pharmaceutical sectors. REACH, CLP, GefStoffV, AMG, AMWHV, BImSchG, ISO 9001, ISO 14001, ISO 45001 – the list of laws, standards and regulations to be observed is long and continues to grow. At the same time, international supply chains, multiple production sites and ever shorter update cycles massively increase the pressure on compliance and quality managers. Many companies try to manage this complexity with Excel spreadsheets, isolated solutions and manual research. But that only works up to a point.
This article shows the specific challenges companies in the chemical and pharmaceutical industries face and how leading companies such as Covestro, Hesse GmbH, WHW Walter Hillebrand and Röchling Medical have found their way to a digital, legally secure compliance organization.
The regulatory environment: Complexity as a constant
The chemical and pharmaceutical industries are among the most highly regulated in Germany and the EU. Compliance managers must simultaneously keep an eye on requirements from multiple legal areas:
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Relevant legal areas in chemicals & pharmaceuticals (selection) Chemicals legislation: REACH (EC 1907/2006), CLP (EC 1272/2008), GefStoffV, ChemG |
In addition, there are regular standard revisions, new EU regulations and site-specific permitting requirements. For companies with multiple sites, this complexity multiplies.
The three biggest compliance challenges for the industry
Challenge 1: A flood of regulation and hard-to-understand legal texts
Laws and regulations are complexly worded and change regularly. Compliance managers must not only keep track, but also ensure that changes are promptly translated into internal processes. Those who do this manually across different platforms and databases risk gaps — and thus liability risks.
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“Another challenge was keeping track of the multitude of legal requirements and understanding them due to their complexity and opaque wording.” — Röchling Medical Neuhaus GmbH & Co. KG, Compliance Team |
Challenge 2: Lack of transparency and unclear responsibilities
In many companies, compliance tasks are spread across different departments — without clear responsibilities and without a central overview. The result: tasks are processed twice or fall through the cracks entirely. Anyone who has to prove in the event of an audit who fulfilled which requirement and when will face a problem.
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“Before we implemented the compliance management software in our company, it was almost impossible for us to delegate and control the multitude of compliance tasks transparently and in a legally secure manner. In addition, the responsibilities for the requirements to be fulfilled were often not clearly defined.” — Hans J. Hesse, Managing Partner, Hesse GmbH & Co. KG |
Challenge 3: High manual effort due to Excel and isolated solutions
Excel legal registers, manual legal research, decentralized documentation — this costs time that is needed for strategic tasks. Especially in companies with multiple sites and many employees, this approach is not scalable.
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“Before implementation, we had a great deal of additional work because we had to search for the applicable laws and guidelines relevant to us on various platforms and compile them in an Excel list.” — Röchling Medical Neuhaus GmbH & Co. KG, Compliance Team |
What really helps: Digital compliance management
These challenges are not isolated cases — they are the everyday reality of highly regulated industries. The good news: they can be solved. Companies that rely on a digital compliance solution consistently report the same benefits:
- Automatic updating of the legal register: Changes in legislation are applied directly, without manual research.
- Clear task delegation: Every compliance requirement is assigned to a person, deadlines are monitored automatically.
- Audit readiness at the push of a button: All evidence is available at any time and documented in an audit-proof manner.
- Cross-site harmonization: Consistent standards across all plants and locations.
- Increased compliance acceptance: Clearly worded tasks foster engagement across the entire company.
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“The greatest benefit of Eticor for us is the translation of company specific laws and regulations into simple and understandable tasks.” — Hans J. Hesse, Managing Partner, Hesse GmbH & Co. KG |
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“Eticor creates significant added value in various areas of our company. We are experiencing a major improvement through the noticeable time savings achieved by optimized processes and a significantly reduced documentation effort.” — Christian John, Safety Engineer, Covestro Deutschland AG |
Practical insights: Companies from your industry share their experiences
The following companies from the chemical, pharmaceutical and chemistry-related industries are already using Eticor successfully and have documented their experiences in detailed success stories:
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Company |
Industry |
Core topic |
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Covestro Deutschland AG |
Chemical industry |
Harmonization and cross-site compliance |
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Hesse GmbH & Co. KG |
Chemicals (coatings & stains) |
Efficient implementation of provisions of compliance |
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WHW Walter Hillebrand GmbH & Co. KG |
Surface finishing / |
Digital and legally secure organizational setup |
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Röchling Medical Neuhaus GmbH & Co. KG |
Plastics / Life Science |
Building a digital compliance organization |
Conclusion: Compliance must be managed digitally.
Anyone working in the chemical or pharmaceutical industry needs a partner who understands the regulatory depth of these industries and knows the challenges. Are your challenges industry-specific? Our compliance solution is, too.
Behind Eticor are over 25 years of experience in compliance management — built in and with highly regulated industries such as chemicals and pharmaceuticals. Our compliance management software Eticor and our consulting services support companies in organizing requirements in a legally secure way and integrating compliance into day-to-day work. Effective compliance does not arise only “top-down” or through task lists, but through clear responsibilities and understanding at all levels. We are happy to support you.
Read the full success stories
Find out in detail how Covestro, Hesse and Röchling Medical solved their compliance challenges.
