ClassicRely on us for guidance. We’ll do what’s required to get your validation study done — with the highest quality standards. |
AdvancedLet’s collaborate. We’ll discuss your specific requirements and customize a validation plan that works for your advanced needs and complex studies. |
Service Levels – Classic & Advanced
Discover an Easier Way to Global Compliance
You rely on our expertise and consultative support to meet your global regulatory requirements. But validation can involve many steps. Choosing the right validation package can be a challenge.Introducing Two New Levels of Service for Better Value and a Better Experience
We make your life easier with a clear and predictable budget, greatly simplified service selection, globally harmonized testing, and as much support as you need. At the same time, standardizing and streamlining our own processes allow us to plan operations better and provide you with a more accurate view of lead times and report dates. What hasn’t changed is our commitment to providing the same expert level of testing, compliance, and support as ever. You benefit from:- A simpler way to order the right validation services at the right time and phase of development.
- A partner that will ensure you meet regulatory expectations for validation.
- The right level of service for your needs, including customized solutions when desired.
Choose the Classic or Advanced Package
We’ve simplified your process from the start with two predefined service levels, and we’ll help you determine the level of service you need. Whichever you choose, our validation experts will be with you at every turn.Our Service Packages
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Satisfies Applicable Global Regulatory Expectations
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Regulatory Query/Inquiry Assistance
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Online Support
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Call-in Support from Project Management Team
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Test Customization1
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Bacterial Retention and Compatibility Study Conditions
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Process duration 48hr max
Cold and room temperature |
Maximum process duration
Maximum process temperature |
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Extractables Study Conditions
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Standard model streams in accordance with industry guidance
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Custom
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Integrity Testing
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1 product lot
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3 product lots
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Templated Documentation
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Customized Documentation
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Documentation Revision
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1
on specific fields2 |
Up to 3 on full document
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Validation Summary Report3
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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 & Process information fields.
3 Validation summary report is integrated when two or more services ordered.