Elevated Assurance Program
Elevated Assurance Program
Elevated Assurance Program – Your raw material partner in manufacturing
In today’s regulated environment, you face increasing demands for compliance with stringent requirements. Partnering with a raw material supplier like us can make a significant difference as you prepare for future regulatory changes. We offer raw materials qualified for manufacturing, complete with documentation and quality services.
Our Elevated Assurance Program instills confidence as you navigate this complex landscape. We provide the necessary documentation to support your audits and risk assessments. Products in this program support your needs for supply chain transparency, as well as manufacturing and quality controls. Additionally, products have the attributes of a M-Clarity™ quality segment of MQ300 or higher as shown in the table below.
By choosing our Elevated Assurance Program, you can count on enhanced support and exceptional quality-related information. Together, we will ensure you are well-equipped to meet your internal and external quality standards.
Audit-Readiness Benefits - Demonstrate Your Commitment to High-Quality Products
- Confirmed process controls to ensure consistency
- Enhanced change notification
- Risk assessment documentation (certificates, impurity profiles and declarations)
- Robust, ready-to-present dossier
Dossier Content Available Free of Charge:
- Site quality assessment
- ISO 9001 certificate
- Product specifications
- Declarations/statements (animal origin content, BSE/TSE, nitrosamine, may vary depending on product group)
MQ300 Level or Higher Products Launched in the Elevated Assurance Program
Upgrading our products to meet quality standards of MQ300 and above will raise the bar in support and services that we provide our customers.
Proteins
Buffers
For more information, contact our experts!
Bovine Serum Albumin
For more information, contact our experts!
White and Dyed Microsphere Beads
For more information, contact our experts!
Fluoroscent Microsphere Beads
For more information, contact our experts!
Magnetic Microsphere Beads
For more information, contact our experts!
Preservatives
For more information, contact our experts!
You asked, We listened
The seal should assure you of product quality. Here’s the meaning behind the design:
- Mountain ranges go from low to high showing our elevation in high quality products and services.
- The check mark, in both the mountain range and negative space, represents the verification and scrutiny the products will go through to make sure the proper documentation and support is ready for customer audits/needs.
- The three peaks indicate our ever-extending offering within the Elevated Assurance Program.
Related Resources
- Brochure: ProClin™ Biocidal Preservatives
ProClin™ preservatives enhance shelf life in over 1,000 FDA-registered IVD kits by inhibiting a wide range of microbes effectively.
- Flyer: For In Vitro Diagnostic Materials: Efficacy vs. Thimerosal and Sodium Azide
Efficacy vs. Thimerosal and Sodium Azide: Traditional preservatives like thimerosal and sodium azide are costly, toxic, and less effective against microbes in in vitro diagnostics.
- Flyer: ProClin™ Preservatives: Questions Addressing Regulatory Concerns
Questions Addressing Regulatory Concerns: ProClin™ products serve the global Medical Devices and IVD sectors, exempt from Biocidal Products Regulation when compliant with relevant directives.
- Flyer: Probumin® Bovine Serum Albumin (BSA)
Albumin is vital in diagnostics, offering stability and binding capabilities. We provide consistent bovine serum albumin with 65 years of expertise.
Online Dossier Available Free of Charge From Product Page
- ProClin™
- Probumin®
- Buffers
- Proteins
- Amino Acids
- Carbohydrates
- Detergents/Denaturants
- High-purity Solvents
- Catalysts
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