Our Products & Innovative Solutions
Accelerate the transformation of your pharmaceutical operations
At salamanderU, we design smart, tailor-made solutions to boost efficiency, ensure compliance, and ensure seamless traceability of your production and quality control processes.
But that's not all: we also simplify the qualification and maintenance of your equipment for time savings and lasting performance.
Thanks to our multidisciplinary expertise, we propel our clients into the Pharma 4.0 era.
Acrylic resin insulators
Robust, compliant and tailor-made aseptic environments
Our custom-designed isolators meet the most stringent industry requirements, whether for regulatory constraints, limited space, or sensitive processes. They integrate seamlessly into a variety of environments, such as:
✔ Fill & Finish of GMP clinical or commercial batches
✔ Innovative therapies / ATMP
✔ Compliance with Annex 1 (EMA / EU GMP)
✔ Preparations in hospital pharmacies
✔ Sites under development or with limited capacity
SmartReg
SmartReg is a voice-activated digital solution that replaces pen, paper and manual interfaces.
Designed for the most demanding environments, SmartReg is the ideal tool for critical situations. SmartReg revolutionizes the way GMP processes are documented and interacted with: faster, safer, and simpler.
✔ Production of GMP clinical or commercial batches
✔ Instant traceability and zero paper
✔ CDMO: agile response to customer quality expectations
✔ Quality Control: minimization of errors, significant time savings
✔ Real digital companion for technical experts for: equipment validation, real-time equipment management and monitoring, preventive and corrective maintenance
SmartEMS
Voice-controlled environmental monitoring integrated into your operations
SmartEMS allows you to monitor and record all critical environmental parameters (pressure, temperature, humidity, etc.) and data from your equipment.
✔ Continuous monitoring of the environment and equipment
✔ Automatic alerts in case of deviation or lag
✔ Compatible with all types of GMP sensors and equipment
SmartUnit
The SmartUnit is a turnkey solution that combines our isolators, SmartReg and SmartEMS
SmartUnit is a turnkey solution that combines our isolators, SmartReg eBR, SmartReg EMS and ERP/LIMS connections.
It is designed to meet the strictest GMP requirements, in fixed or mobile spaces, for aseptic production.
✔ Complete integration: isolator, digitalization, monitoring
✔ Quick and customizable installation according to your needs
✔ Mobile, scalable, and GMP compliant
Why Choose SalamanderU Solutions
Technologies designed to meet the challenges of Pharma 4.0
Our solutions aren't just innovative; they're designed "by users, for users." We adapt to your needs, enhance your performance, and ensure regulatory compliance. With our tailored approach, we support you every step of the way.
Compliance & Reliability
✔ 100 % complies with GMP standards (GMP, Eudralex Vol. 4, FDA 21 CFR Part 11)
✔ Automatic recordings, complete audit trails
✔ Enhanced security and real-time traceability
Performance & Profitability
✔️ Up to 30 % reduction in operational costs
✔️ Optimization of production flows and quality control
✔️ Acceleration of quality reviews and market launches
Flexibility & Support
✔️ Customized solutions to your processes and constraints
✔️ Centralized control, even for your remote or outsourced sites
✔️ Project support from design to validation
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