Regulatory Compliance & Supply Chain Excellence

 Regulatory Compliance

Our regulatory expert teams support a high-performance supply chain to ensure delivery of Life Science products on time, every day.

Department Overview

Different regulatory teams work hand-in-hand to provide regulatory excellence for our Life Science business.
 

Regulatory Excellence

Regulatory Excellence at a Glance
 

Regulatory Management

The Regulatory Management team is responsible for product submission and consumer protection.
 

Specific Products • Submission/registration of e.g. API, biologics, medical devices
• Import/export licenses and facility licenses in the context of animal by-products
• Registration of electrical appliances
• Registration for the intended use of the product
Biological Materials • Management of US Import Permits
• Management Technical Product facility licenses and related authority inspections
• Management of research use only (RUO) products derived or containing animal materials
• Export documentation for animal by-products, e.g. Veterinary Certificates, declarations
• Animal Science and Welfare governance role for Life Science
• Global advocacy and surveillance activities for animal by-products
• Animal Origin Statements
Medical Device Equipment • Preparation of regulatory technical files for registration (International)
• Preparation of regulatory submissions (FDA)
• Vigilance / Adverse event / Medical device reporting
• Support to authority inspections
• Coordination of testing & certification / Reports for electric equipment
• Annual registrations
Pharma & Food Materials • Preparation of regulatory technical files for registration
• Regulatory activities and support for pharma raw materials, food contact materials, dietary ingredients,
  flavors & fragrances
• Systematic approach to monitor regulatory developments
Regional Hubs in APAC,
LATAM & EMEA

 

• Develop and implement standardized regional processes and practices
• Tracking and maintenance of regional fillings, licenses, registrations
• Provide regional advice and counsel for subsidiaries
• Liaison between subsidiaries and global regulatory organizations

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Trade Compliance

The Trade Compliance team is supporting our customers with legal compliance expertise in domestic and international trade.

Our Company is committed to upholding best-in-class trade compliance standards to ensure our customers’ access to a secure and protected supply chain. Our mission is to create and sustain the requisite conditions for trade and product compliance to pursue maximum customs and excise tax benefits for all imports and exports.

The operational scope of the Trade Compliance department is primarily comprised of the areas of Customs Management, Product Compliance, and Trade Controls.

Our global team of trade compliance professionals works closely with business areas, supply chain units and local subsidiaries to provide guidance, oversight and governance in a constantly changing regulatory environment. To stay ahead of shifting trends, we place paramount importance in forging trusted relationships with our regulating authorities to ensure the highest level of supply chain continuity for our customers.
 

   
• Customs Management
To ensure the movement of products through customs jurisdiction is unobstructed by regulatory inefficiencies. Notable responsibilities include customs import management, broker management, foreign trade zone operations, customs export management, import/export filing, origin marking requirements, and free trade agreements implementation.
  • Product Compliance
To ensure the proper classification of all products and their assignment to applicable regulatory controls. Notable responsibilities include import and export control classifications, customs tariff code classifications, and product review in new product introductions.
  • Trade Controls
To ensure that all business transactions are properly screened. Responsibilities include license management, order review and release, sanctioned party list screening, deemed export and controlled technology reviews, site registrations maintenance, embargo restrictions, and regulated chemical/ethanol program management.


Effective Trade Compliance Programs

The Trade Compliance department establishes effective compliance programs to ensure regulatory compliance throughout the entire supply chain.

The product portfolios of life science companies are exposed to national and international regulations which impose various license, registration and reporting requirements. In collaboration with our business units and external business partners, our Trade Compliance department establishes effective compliance programs to ensure regulatory compliance throughout the entire supply chain.

Trade Compliance Expertise

Our commitment to Trade Compliance excellence allows our global customers access to an expanding portfolio of highly regulated products.

We provide efficient and compliant control processes for critical and highly regulated products that are subject to a variety of national and international control regimes, which include but are not limited to:

  • Control of Drug Precursors and Narcotic Substances (e.g. INCB or DEA)
  • Export Control of Dual Use Goods and Technology (Wassenaar Arrangement, Australia Group, NSG, MTCR)
  • Chemical Weapons Convention and Biological Weapons Convention
  • Control of Ozone Depleting Substances and Hazardous Substances (e.g. Montreal Convention or PIC Convention)

We have a network of trade compliance professionals located in more than 30 countries worldwide, that is responsible for a broad service portfolio.

Our local presence and profound regulatory experience that is represented in all important market regions allows our company to manage country specific import and exportation requirements in a cost effective and legally compliant way. Our service portfolio includes but is not limited to:

  • Licensing, registration and reporting procedures
  • Denied party screening and embargo controls
  • Export control classification, customs tariff classification
  • Excise duty management
  • Free trade agreements
  • Free trade zones and bonded warehouses

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Dossier: Brexit Preparedness

Hazard Communication & Chemical Regulations

The Hazard Communication and Chemical Regulations department is responsible for implementing global regulatory requirements for placing compliant chemicals on the market and for their safe use based on a proper hazard communication.
 

   
• Hazard Communication
In line with our corporate commitment to Responsible Care and as a trusted partner of our customers, we provide up-to-date, compliant and high-quality hazard information in the areas of Safety Data Sheets, Product Labels and Dangerous Goods, thus ensuring the global marketability of our products.
  • Global Chemical Registrations
We enable marketing by taking care for the registration, notification and authorization activities of our comprehensive Life Science portfolio by complying with the Chemical Regulations in our target markets.
  • Regulatory Excellence and Efficiency
To improve our internal regulatory processes, systems and services for our customers, continuous improvement is part of our DNA. Therefore, dedicated experts in Lean & Six Sigma as well as project management systems are challenging our established processes and systems to enable future growth and additional alliances for our Life Science businesses.
 
  • Regulatory Intelligence
We are advocating several aspects of Classification and Labeling of our chemicals. Therefore, we substantially drive the global implementation of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) within the Merck KGaA Group facing many specialties based on our unique and outstanding Life Science portfolio and services. Due to our well-established and recognized expertise, we are advocating hazard communication regulations on national, EU, as well as UN-levels by addressing specific aspects of the Life Science sector.
  • Continuous Improvement
We believe in challenging the status quo with a continuous improvement mindset. The scientific world is changing rapidly and so we do as well. What was sufficient yesterday does not necessarily fulfill our requirements and the expectations of our customers for tomorrow. A structured process serves for the identification and prioritization of Regulatory Excellence projects. A targeted continuous qualification strategy is implemented through all hierarchy levels.
  • Continuous Improvement through Lean & Six Sigma
Lean & Six Sigma are the operational excellence tools applied by our experts to streamline and develop our processes and implement new workflows and systems. The Lean & Six Sigma team drives the implementation of the excellence strategy and mind set within our organization. Processes are identified; new processes are designed. Existing processes are analyzed by means of Lean & Six Sigma methods and optimized with respect to effectiveness and efficiency.

Hazard Communication

The Hazard Communication team is working closely at the interface between product managers, distribution and supply chain. We have end-to-end responsibility for processing of regulatory product data including a governance mandate to ensure overall compliance.

In a highly regulated environment in which any new regulation can be considered a potential market entry barrier, we perceive every regulatory challenge as a competitive advantage to meet customer expectations. By combining outstanding experience in the areas of Chemical Regulations, Toxicology and IT we are implementing smart digital solutions to ensure global marketability and increase product safety for our customers.

It is our overall aim to:

  • Protect the health and safety of our customers, employees and business partners
  • Avoid any environmental risks when handling our products

Bundled within our Hazard Communication department are all activities around:

  • Safety Data Sheet authoring
  • Regulatory Toxicology
  • Dangerous Goods Management
  • Product Label Management

Global Chemical Registration

Fulfilling the global regulatory requirements and conducting registrations, notifications or authorizations where required, is the license to operate for our Life Science business.

More than 300,000 chemical identities are part of our Life Science business. Ensuring that all of them fulfill the regulatory requirements globally is the job of the Global Chemical Registration team. One of the daily challenges: meeting constantly changing chemical and biocidal requirements in the regulatory environment.

As a globally leading company in Life Science, we take all necessary regulatory actions to continue to expand the supply of our products to our worldwide customer community. The main focus in this regard is the known highly regulated markets, like the European Chemical Regulation REACH within the European Union. Since REACH serves as the blue print for new regulations within the USA, China, Korea or Turkey, we can benefit from our comprehensive experience and the global setup with EU REACH to create added value for our customers and ensure compliant products.

In parallel, new regulatory programs are also in focus since they become more and more important for market entry. Therefore, we assess the impact of new regulations on the Life Science business and set up the necessary tools and processes.

Learn more about the European Chemical Regulation REACH:

Regulatory Systems & Processes

We globally enable innovation in regulated markets through smart solutions and by driving digitalization. A strong focus on our work and our responsibility is the handling of regulatory master data.

To enable the reliable handling of data and information we have a strong focus on IT systems and processes. To provide our global customer community a growing product portfolio with best regulatory support (e.g., through high quality Safety Data Sheets or enabling the delivery of our products within 24 hours), it is our ambition and strong belief that:

  • Everything that can be digitalized will be digitalized
  • Everything that can be connected will be connected
  • Everything that can be automated will be automated

Therefore, we are continuously driving projects and developing tailor-made systems to fulfill our stringent quality requirements.

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 Supply Chain Excellence

Continuous supply and consistent quality are the foundations that form our partnership with our customers. Providing Customer-Focused Supply Excellence is at the center of what we do.
 

Supply Chain Excellence at a Glance

Supply Chain Excellence at a Glance

Close Collaboration with Integrated Supply Chain Operations

Our Quality and Regulatory team works hand-in-hand with our Integrated Supply Chain Operations team to establish:

  • Technology-focused manufacturing teams, assuring the best process capabilities to deliver quality products on time to our customers
  • A large and strategic network of global distribution centers assuring the right product is in the right place, at the right time, to meet our customers’ needs
  • Sophisticated and customer-aligned supply chain capabilities to assure fulfillment of customer needs at the highest level, across more than 300,000 products

We ensure quality by:

  • Launching new innovative products into existing plants and adhering to our strict quality policies and practices
  • Supporting the continuous improvement of products through a Quality Customer Care process and dedicated Quality Services
  • Providing a partnership to support older product claims, capability and other needed improvements
  • Helping to drive and support a quality-driven culture
  • Driving and supporting manufacturing changes that impact product performance, claims, raw materials, plant transfers, suppliers and more

We ensure supply through:

  • Long-range planning to support decision making for capacity and other needed investments
  • Short-term planning support to prevent back orders
  • Being a partner and promoter of business continuity planning and supply security
  • Understanding Life Cycle Management to help margin, growth opportunity and costs
  • Providing manufacturing locations for our products that span across the entire Integrated Supply Chain Operations Network

Integrated Supply Chain Operations Footprint

Supply Chain Operations Footprint

Supplier Quality Management

The Supplier Quality Management program is designed to manage effective control over the quality of all procured products, processes and services that directly or indirectly support material provided to our customers.

The Supplier Quality Management group provides oversight of the program by:

  • Maintaining and ensuring the Supplier Quality Management procedure complies to our corporate group quality standard for Supplier Quality Management.
  • Training, assessing, monitoring and assisting Life Science sites in the implementation of all aspects of the Supplier Quality Management program as outlined in the procedure.
  • Maintaining the Supplier Quality Management program in response to industry and regulatory trends, customer requirements and business needs.

Supplier Assessments & Audits

All Life Science sites perform an annual categorization of suppliers and create an audit/assessment schedule.

Supplier Categorization

 

Assessments are accomplished through supplier self-survey questionnaires, on-site audits, or a combination of both. Questionnaires have related scoring sheets.
 

Categorization of Supplier Assessment Frequency Method of Assessment
Critical Chemicals: Once every three years
Non-Chemicals: Once every 2 years
On-Site Audits
Essential Once every three years Questionnaire and Audit as Determined
by Risk Assessment
Non-Critical N/A As determined by site level procedure

Learn more about Supply Chain Risk Mitigation (PDF)