Safety in Life Sciences
Through Integrated Partnership
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EU MDR Compliance
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Risk Management
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Chemistry for Toxicology
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Sterilization Process Validation
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Biocompatibility
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Clinical Evaluations
| EU MDR Compliance | Risk Management | Chemistry for Toxicology | Sterilization Process Validation | Biocompatibility | Clinical Evaluations
Our Services
Biocompatibility Evaluation & Test Subcontracting
ChemTox® — Leachables / Extractables & Toxicology
Sterilization Process Validation & Maintenance
EU MDR: Planning & Technical File Remediation
Clinical Evaluations
Risk Management & Device Usability
How Gezellig Scientific helps
Gezellig is your partner in assuring product safety and facilitating robust and compliant documentation. Our team of experienced professionals partner with our clients to provide unique solutions to challenging problems. Whether you’re a startup looking for a full suite of services or a large organization needing support in a specific area, Gezellig has the expertise to help.
Quality assurance each step of the way
Need Evaluation
Each engagement is unique and we approach them as such. True understanding of the need helps us to ensure the adequacy of the proposed approach.
Solution Road-Mapping
To support the engagement, the interaction is mapped and documented in an official scope of work to ensure agreement and common understanding.
Custom-Tailored Process
The output of all activities are documented in whichever way best suits the needs of the customer, most often within their own documents and templates.
“We had no idea where to start with sterilization validation for our products, Gezellig Scientific trained us and made our device registration possible ”
-Joe T.
Gezellig Scientific offers end-to-end service throughout the entire regulatory approval process.
