Scapa Healthcare Supports Customer Transition from In-House to Contract Manufacturing for Advanced Molecular Iodine Technology
September, 2023
Summary
- A medical-grade dental rinse manufacturer was rapidly growing and needed a qualified manufacturing partner to help expand capacity.
- The company turned to the team at Scapa Healthcare for its expertise in medical-grade liquid contract manufacturing services.
- Scapa Healthcare created a comprehensive manufacturing process, enabling the customer to concentrate on its core competencies in research and development.
Challenge
A medical-grade dental rinse manufacturer with groundbreaking antimicrobial technology in the dental, medical, consumer, agricultural, and pet healthcare industries (the customer) faced a challenge when sales grew drastically, and distribution expanded nationally through a partnership with national retailers and medical distributors.
The customer's impressive growth presented a unique challenge: the product’s success quickly outpaced its self-manufacturing capabilities, and additional resources and capacity were needed to meet increasing demand. They recognized the need to find a reliable contract manufacturing partner to help scale their operations.
Solution
The customer turned to the Scapa Healthcare Technology Center in Dallas, TX, due to its experience in medical-grade contract manufacturing and because of recommendations from other satisfied healthcare manufacturers. Scapa Healthcare provided complete manufacturing services and analytical testing expertise under Current Good Manufacturing Practices (CGMP) requirements.
The partnership brought several critical benefits to the customer that significantly enhanced its capabilities and competitive advantage, including:
- Compliance and Regulatory Support: Scapa Healthcare's robust Quality Management System (QMS) ensures the highest quality and compliance. It provides the foundation for a tightly controlled manufacturing process, ensuring the product meets stringent industry standards, including FDA requirements. This gave the customer confidence in maintaining its regulatory standing while relieving them of the burden of navigating complex regulatory landscapes.
- Testing and Validation: Scapa Healthcare supported the customer with seamless execution of testing and validation for its active dental rinse ingredients.
- Smooth Technology Transfer: Scapa Healthcare facilitated a smooth technology transfer, onboarding the customer's proprietary formulation processes into the Dallas location. By working closely with the customer's technical team, Scapa Healthcare ensured the technology transfer was completed under their specifications.
- Medical Device Certifications: Scapa Healthcare is registered as an OTC and Medical Device manufacturer with medical device certification, giving it a competitive edge over other contract-filling manufacturers, ultimately enhancing the customer’s product quality and reliability.
- Synergies with Key Partners: Scapa Healthcare has existing relationships with key industry partners, including the national medical distributors, creating new opportunities for the customer to expand their commercialization channels.
Results
- Through strategic collaboration, Scapa Healthcare and the customer demonstrated the value of an efficient and reliable contract manufacturing partnership.
- Scapa Healthcare enabled the customer to free up internal resources to focus on its core capabilities in R&D by leveraging the company's manufacturing and testing expertise.
The customer can now scale its operations, maintain FDA compliance, and pursue future growth opportunities cost-effectively.
LOOKING FORWARD
Scapa Healthcare's reliable, responsive, and excellent communication processes made the partnership even more successful, leading to future opportunities. For instance, leveraging Scapa Healthcare's contract manufacturing expertise and established industry relationships, the customer envisions future partnerships to produce an active wound cleanser and oncology oral care products.
ABOUT SCAPA HEALTHCARE
Scapa Healthcare is the trusted strategic partner of choice for the world’s leading companies in advanced wound care, consumer wellness, and medical device fixation. Our deep understanding of the markets we serve allows us to leverage our manufacturing, technology, and development expertise to deliver innovative skin contact solutions that help our customers succeed in the marketplace. Scapa Healthcare offers Regulatory Services for Medical Devices.