Custom
Consulting Services
Projects are custom in nature, designed for your specific needs. This is a sampling of typical types of projects. Don't see what you need? Reach out for a free consultation.
1
Extractable/Leachable Strategy Support
Test plan support to meet current regulatory requirements. Chemical characterization testing protocol reviews. Assistance with technical questions from regulatory agencies.
2
Chemical Characterization Training
Customized training for you and/or your team on the elements of extractable/leachable testing as it relates to ISO 10993-18 for medical devices and how it can be used to support your overall biocompatibility test strategy per ISO 10993-1. USP<1663>, USP<1664> and USP<665> for pharmaceutical components as well as training for combination products.
3
Technical Audit Support
Specialized auditing services designed for manufacturers seeking to evaluate the performance, reliability, and compentanies of third-party analytical laboratories. Technical audits ensure that your partners meet the highest standards in chemical analysis, data integrity, and regulatory alignment—protecting your products, reputation, and supply chain.
4
Expert Advice On Demand
Embedded strategic support for laboratory operations, regulatory alignment, biocompatibility support and scientific credibility, o
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