Validation and Qualification Services

In the Life Science industry, robust processes and effective technology management are essential to ensure consistent product quality throughout the product lifecycle. S4BT provides comprehensive Manufacturing Science & Technology (MS&T) support, helping organizations manage, optimize, and validate...

Meissner is the industry’s premier choice for critical freeze and thaw operations, delivering unmatched security and performance at every scale. Whether you’re working with small process development (PD) volumes or full commercial scale production, Meissner provides the most secure platforms on the market—...

Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes method development, validation and transfer. Kymos has comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary method...

Iskra PIO delivers innovative solutions for safe and ergonomic handling of raw materials in cleanroom environments. Our systems streamline the preparation of mixtures by integrating milling, sieving, compacting, transferring, and packaging into one efficient process. Operators work safely from the ground, ...

Effluent de-contamination system is mainly used in bio-pharmaceutical enterprises/laboratories, research institutes and other entities. The bio-active waste water discharged during production often contains some living bacteria and viruses of great hazard. Sterilization is necessary to kill pathogens ...

Verifarma Track & Trace es una plataforma robusta de serialización y agregación diseñada para ayudar a las compañías farmacéuticas a cumplir con los requisitos regulatorios globales, con especial atención a la Directiva Europea sobre Medicamentos Falsificados (EU FMD) y el marco EMVO.

La ...

We have over 20 years’ experience managing sterilization of medical devices

The demand for single use sterile medical devices is growing, and there are real benefits to externalizing your sterilization to a specialist service provider. Ensera’s long-standing relationshi...

TP&C provides comprehensive quality control and analytical testing services to support product safety, consistency and regulatory compliance. Services include analytical testing, stability studies and quality assurance processes to ensure product compliance, performance and safety throughout developmen...

We take responsibility for releasing your drug batches in accordance with the requirements of the EU GMP guidelines and the German Medicinal Products Act (AMG).

Our services at a glance: • Batch release in accordance with EU GMP Annex 16 by our QPs • Batch certification for human and veterinary...

Contract analyticsDevelopment of analytical methods (chromatography – dissolution – particle analysis – titration – wet chemistry)
Formulation screening and compatibility testing for product development
Biopharmaceutical characterization
Specialized analytical methods – special analyses
GMP or ...

The UTPVision 01942 Calibration ACCREDIA is a calibration centre accredited by ACCREDIA and it’s able to issue calibration certificates with the guarantee of metrological traceability to the International System of Units.
Discover more: https://utpvision.com/it/...

MANUFACTURED IN ACCORDANCE WITH GMP STANDARDS 

LAMINAR/TURBULENT 

OPERATION IN OVERPRESSURE OR UNDERPRESSURE MODE 

AUTOMATIC LEAK TEST 

HEPA FILTRATION H14 

CHECKING FILTER CONTAMINATION

MOCK-UP,  FAT, SAT,...

Catalyx employees are deployed onto a client site to integrate into the client’s team(s) to supplement their internal headcount, these embedded resources work under the client’s supervision for specific roles.

-  Managed, Flexible & Scalable Solutions 
-  GMP Expertise &a...

 Instead of using traditional LAL reagents, Fujifilm Wako also offers a new alternative of endotoxin detection reagents developed by recombinant technology. It mimics the traditional LAL reagents cascade of three recombinant factors (Factor C, Factor B, and proclotting enzyme) and the pNA chromogenic ...

Looking to establish your own in-house FFS combination cap production facility? JSD provides turnkey production solutions covering cap manufacturing, material compounding, sealing-disc production, and ongoing technical support. Contact JSD today to discuss your requirements and discover how we can help bri...

Our in-house Industrial R&D Center with over 80 specialists, provides advanced support for optimizing pharmaceutical processes. We cover the entire plant lifecycle, from design to validation, focusing on critical issues such as rouging, leakage, sterility failures, material wear, and malfunctions.Using...

Container Closure Integrity tester is a non-destructive, non-invasive, 100% In-line Validation for leak proof Container. CCIT measurement technology based on the following testing methods;

i)               ...

Fully automated system to determine the quality of Auto Injectors.

 
- Pen Injector Batch Release – Sample Test

    - Semi-automatic system:

    - Manual loading / unloading

    - Fully automated inspection q...

JD Pharma Consultants Pvt.Ltd. is leading Pharmaceutical Project Consulting company offers services from design upto commissioning of Pharmaceutical project.Our services includes Plant layout design, HVAC, Civil, Electrical, mechenical, Clean room design & installation. We provide end to end solutions to o...

In the highly regulated Life Science industry, reliable and compliant computerized systems are essential for product quality, data integrity, and operational efficiency. S4BT provides Computer System Validation services throughout the lifecycle of digital and automated systems.

Our experts suppo...