Validation Service Levels

Meeting global regulatory requirements demands a high level of expertise and consultative support, with validation often involving many steps. To help you choose the right validation package, BioReliance^® Validation Services offers two levels of service for better value and a better experience. Our standardized packages make your life easier with these benefits: 

• Clear and predictable budgeting
• Greatly simplified service selection, at the right time and phase of development
• Globally harmonized testing
• Precisely as much help as you need, with our trademark commitment to expert testing, compliance, and support

Whichever you choose, our validation experts will be with you at every turn.

Choose from Classic or Advanced packages

We’ve simplified your process from the start with two predefined service levels.

• Classic: Rely on us for guidance. We’ll do what’s required to get your validation study done – with the highest quality standards.
• Advanced: Let’s collaborate. We’ll discuss your specific requirements and customize a validation plan that works for your advanced needs and complex studies.

Service Level Comparison Chart

Service Level Comparison Chart	Classic	Advanced
Satisfies Applicable Global Regulatory Expectations	✓	✓
Regulatory Query/Inquiry Assistance	✓	✓
Online Support	✓	✓
Call-in Support from Project Management Team	✓	✓
Test Customization1	-	✓
Bacterial Retention and Compatibility Study Conditions	Process duration 48hr max   Cold and room temperature	Maximum process duration   Maximum process temperature
Extractables Study Conditions	Standard model streams in accordance with industry guidance	Custom
Integrity Testing	1 product lot	3 product lots
Templated Documentation	✓	-
Customized Documentation	-	✓
Documentation Revision	1   on specific fields2	Up to 3   on full document
Validation Summary Report3	-	✓

¹ Classic testing covers predetermined range of process conditions with defined study parameters. Advanced testing provides higher level of customization including process conditions,
     additional test equipment/resources and more complex study requirements.
² Drug product and Process information fields.
³ Validation summary report is integrated when two or more services ordered.

Discover an easier way with BioReliance^® Validation Services. Contact us to request a quote or discuss the service level that is right for you.

Choosing the Right Validation Services

Related Product Resources

Data Sheet: Test Parameters by Service Level
BioReliance^® Validation Services Global Brochure