Client Overview

One of Europe’s largest protein bar manufacturers, ranking third in their market, sought to expand into the U.S. market. Despite their success in Europe, they faced significant challenges in meeting U.S. regulatory requirements and establishing distribution operations.

Challenge

The client initially assumed their European standards would transfer to the U.S. market, but quickly discovered:

• U.S. requirements differed significantly from European regulations
• Complete all required documentation for selling in the U.S.
• Product formulations needed substantial modification
• Packaging and labeling required complete overhaul
• Quality control processes needed restructuring
• Cold chain logistics required different approaches in the U.S. market

Our Solution

U.S. Regulatory Compliance

• Conducted comprehensive FDA requirement analysis
• Completed business entity registration
• Guided product reformulation to meet U.S. standards
• Managed new nutritional testing protocols
• Developed compliant labeling and packaging
• Secured necessary certifications and approvals

Distribution Infrastructure

• Established two strategic warehouse locations
• Implemented U.S.-specific cold storage solutions
• Created distribution network aligned with U.S. retailer needs
• Set up quality control systems meeting FDA requirements

Logistics Management

• Developed U.S.-compliant documentation systems
• Created temperature-controlled supply chain
• Implemented U.S. inventory tracking standards
• Established product testing protocols for U.S. compliance

Business Operations

• Set up U.S. business entity
• Managed customs and import procedures
• Established relationships with U.S. retailers
• Created U.S.-specific standard operating procedures

Results

Regulatory Success

• Successfully reformulated products for U.S. market
• Achieved FDA compliance across product line
• Established U.S.-standard quality control systems
• Created compliant documentation processes

Operational Achievements

• Launched two fully operational U.S. warehouses
• Established reliable cold chain distribution
• Created efficient coast-to-coast delivery system
• Built strong relationships with major retailers

Business Impact

• Successful entry into U.S. market
• Cost-effective distribution system
• Streamlined regulatory compliance
• Foundation for scalable growth

Key Success Factors

• Deep understanding of U.S. FDA requirements
• Strong logistics and warehousing expertise
• Effective regulatory navigation
• Comprehensive business support

Client Benefit

The client gained:

• Confidence in U.S. regulatory compliance
• Reliable distribution infrastructure
• Cost-effective operations
• Platform for U.S. market growth