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Regulatory Compliance in the Chemical and Pharmaceutical Industries

Centralized control and verifiable at any time

Keep regulatory requirements, standards, and audits under control at all times.

Regulatory requirements in the chemical and pharmaceutical industries are becoming increasingly complex, audits more demanding, and documentation requirements more extensive. At the same time, there is often a lack of transparency regarding the current compliance status, clearly defined responsibilities, and reliable evidence.

Eticor helps you centrally manage regulatory requirements, identify risks early on, and provide verifiable proof of compliance at all times.

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A lab technician wearing protective gear and using a tablet inspects a production line in a cleanroom.
Everyday Reality

What Really Weighs on Compliance Officers

Whether you're a CCO, a quality management leader, or an EHS manager, you know these pain points from personal experience. So do we.

  • Audit and DocumentationPressure Regulatory inspections, GMP audits, EMA and BfArM approvals, FDA inspections, and ISO certifications all require reliable documentation at all times. A lack of documentation or unclear responsibilities can quickly lead to nonconformities, corrective actions, or reputational damage.

  • Lack of Transparency Across Locations and Companies
    Different plants, subsidiaries, and departments operate using their own processes and lists. The actual status of compliance measure implementation often remains unclear.

  • Regulatory Complexity
    REACH, CLP, AMG, GMP, ISO standards, ESG requirements, and international regulations are constantly changing. The challenge is not simply knowing about these changes, but implementing and demonstrating them across the entire group.
  • Too Many Systems and Silos
    Compliance, QHSE, quality management, and environmental management often operate in separate systems. Duplication of effort, data discontinuities, and inconsistent data make efficient management difficult.

  • Personal Liability & Risk ofFines
    In the chemical and pharmaceutical industries, violations can result in substantial fines and personal liability. An overlooked change in a standard can have dire consequences.

The Eticor Solution

More Than Just a Legal Registry

Eticor helps companies manage regulatory requirements, ISO standards, and industry-specific standards through a single, centralized platform.

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Ensuring the Smooth Implementation of Legislative Changes

Changes to laws and standards are identified, translated into easy-to-understand tasks, and automatically entered into your legal registry . Responsibilities, deadlines, and implementation status remain traceable at all times.

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Creating Group-Wide Transparency

All locations, plants, and departments operate on a central platform. Management, Compliance, and QHSE have an up-to-date overview of risks, measures, and compliance status at all times.

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Dashboards & Compliance Status

All relevant information regarding requirements, measures, and supporting documentation is available in one central location. This allows you to identify areas requiring action early on and to demonstrate your current compliance status to auditors, regulatory authorities, and management at any time.

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Audit Documentation at the Click of a Button

Whether it’s a GMP inspection, ISO certification, or a regulatory audit: All required documentation is available in a centralized and traceable manner. This significantly reduces the amount of preparation work and provides peace of mind during audits and inspections.

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Employee Workshops & Compliance Culture

Targeted workshops not only impart knowledge but also foster acceptance of regulatory requirements. This creates a shared understanding of compliance, quality, and responsibility.

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We Take Responsibility

Eticor assumes responsibility for the completeness and accuracy of the legal cadastre, including the specific tasks, based on the documents and data provided by the contracting party at the time of the inventory.

89 hours less monthly operational compliance effort*
100% Faster identification of and response to compliance issues**
64% greater transparency regarding compliance risks**
Sources *Master’s thesis by Elisabeth Körbs, “Critical Analysis of the Costs of Implementing and Maintaining a Digital Compliance Management System,” Aschaffenburg University of Applied Sciences, 2022. Comparison of a legally compliant target state (151.7 hours/month) with software-supported compliance management (62.4 hours/month). **PwC, Global Compliance Survey 2025 (1,802 executives from 63 countries). Companies report that compliance technologies provide: • 64% greater transparency regarding risks, • 53% faster identification of and proactive response to compliance issues. 
Our Value Proposition

Everything you need—all in one place

Latest Regulatory Changes
Early-warning system for new laws, revisions to standards, and EU regulations—automated, evaluated, and presented in a way that enables action.

  Comprehensive compliance software
SaaS platform featuring a legal database, document management, audit management, KPI dashboards, and seamless ERP integration.

 

Employee Workshops & Training
Customized compliance training for your teams—from awareness training to certification preparation.

  Expert contacts when you need support
Our compliance experts are here to assist you with their professional expertise and practical support.

 

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Legal Modules

Industry-Specific Modules for Pharmaceuticals & Chemicals

Eticor covers all relevant areas of law: comprehensively, up-to-date, and specifically tailored to the needs of your industry.

Pharmaceuticals & Medical Device Law
TOUCH
Pharmaceutical and Medical Device Law
Pharmaceutical and Medical Device Law

AMG, AMHV, AMWHV, MPDG, MPBetreibV, GDP, ISO 9001, ISO 13485, ISO 9001

Chemical & Hazardous Substance Management
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Chemical and Hazardous Substance Management
Chemical and Hazardous Substance Management

REACH, CLP, ChemG, GefStoffV

system-specific
TOUCH
Environmental and Plant Safety
Environmental and Plant Safety

Federal Immission Control Act (BImSchG), Waste Management Ordinance (AwSV), Major Accidents Ordinance, Waste Management Act (KrWG), ISO 14001

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TOUCH
Occupational Safety & EHS
Occupational Safety & EHS

ArbSchG, BetrSichV, ISO 45001


ESG & Supply Chain
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ESG & Supply Chain
ESG & Supply Chain

CSRD, ESRS, LkSG, CSDDD, EU Taxonomy

Compliance & Governance
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Compliance & Governance
Compliance & Governance

ISO 37301, Whistleblower Protection Act

Digitalization & Information Security
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Digitalization & Information Security
Digitalization & Information Security

ISO 27001, NIS2, GDPR, AI Act

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Real-World Perspectives

What Compliance Officers Say About Eticor

Excerpts from our success stories in the chemical and pharmaceutical industries —from people who face similar challenges in their day-to-day compliance work.

Compliance Blog

Always Up to Date in the Area of Compliance

In our blog posts, we keep you up to date on current topics and expert insights regarding compliance, digital transformation, and Eticor.
 
Compliance Blog
Request a demo

What to Expect in the Demo

In 30 minutes, we’ll show you how Eticor solves your specific compliance challenges in the chemical and pharmaceutical industries—live and with a practical focus.

  • Live demo of the software featuring your specific use cases
  • One-on-one consultation with a compliance expert from your industry
  • Customized module recommendations based on your areas of law
linda brand
Linda Brand
Wirtschaftsjuristin (LL.B.)
Project Manager Sales
l.brand@eticor.com
+49 151 1636 2756
tim bieber
Tim Bieber
LL.M.
Legal Compliance Expert
t.bieber@eticor.com
+49 6022 2656 127
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