Technology and Software (Biopharmaceutical Services)

ProPharma's validation professionals leverage the latest risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques to ensure that our clients' systems are ready for inspections from the FDA, EMA, MHRA, and other regulatory agencies. Our consultants have extensive experien...

SoftGroup® SaTT EU Hub Gatewayoffers an upload/update of PMD (Product Master Data) and PPD (Product Pack Data) to the EU HUB (EMVO). Via this Cloud solution, the MAH / Parallel distributor could select which serialized batch should be reported to EMVO. The system allows status verification o...

We specialize in IA and non-AI Computer System Validation, equipment validation, utilities qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, and other key Life Science authorities across Europe and the Americas. With a proven trac...

POWERFUL SERIALIZATION AND TRACEABILITY SOLUTION FOR L4-L5, NOW PART OF THE OPTCHAIN™ PLATFORM OPTEL’s L4-L5 serialization software, a powerful, enterprise-level serialization and traceability solution, has helped the world’s best-known brands protect their assets. Optchain Verify is an essential tool ...

Digitization solutions for preventive and predictive maintenance:

Rise to the challenges of digitalization with the Rommelag Pharma Platform. This sophisticated solution honors the strict compliance stipulations of the pharmaceutical industry while leveraging automated tech...

Biology, chemistry and pharmacology data -all in one place. Accelerate drug development with early, comprehensive intelligence. Collating the necessary data to identify the likelihood of a drug's success as early as possible requires considerable resources. Cortellis Drug Discovery Intelligence(TM) ...

As a busy parent, managing a child's medication can be hard. Team Consulting integrated connectivity into a syringe to help parents keep track of their child’s medication through a smartphone app.

Using a small, low-cost sensor, this connected syringe automatically tracks when and how much drug...

YAVEON ProBatch is a cloud-based ERP solution built on Microsoft Business Central, offering specialized features for pharmaceutical companies, such as batch management (including traceability), quality control, recipe management and more. With YAVEON's validation consulting, experts are at your side to val...

Entvin's Formulation AI accelerates drug development with advanced AI-driven automation. It streamlines data analysis from FDA, EMA, and other sources, enhances R&D efficiency, and simplifies complex formulation tasks. By integrating AI, Entvin optimizes time-to-market, ensures timely approvals, and su...

Deliver your clinical breakthrough to market in record time. With kp’s next generation BlisterPro® services, you can gain a true competitive, cost-effective edge with turn-key blister package design, finite element analysis, tooling design, fabrication, and package production. As the leading pharmaceutical...

OCEAView™ is a unified platform based on three key pillars: monitoring, traceability, and alerts. Designed for fixed monitoring, mobility, and connectivity, OCEAView™ integrates a wide range of advanced data loggers and wireless sensors to help you stay on top of your critical environments and monitor your...

Increase successful submission outcomes in markets worldwide with comprehensive, expertly analyzed regulatory and market access information 1. Get treatments to patients faster Compare and monitor regulations quickly across markets to understand regional health technology assessment (HTA) outcomes. 2. Main...

Designed in France, the Cobalt X logger can accommodate up to 4 external sensors simultaneously to monitor your sensitive equipment. Readings are recorded in the internal memory and then transmitted to the OCEAView platform via LoRaWAN or Bluetooth. The Cobalt X is equipped with an interactive touchscreen ...

Cobalt XS is the latest addition to Dickson's range of data loggers for the OCEAView monitoring solution. Offering a small footprint and LoRaWAN wireless connectivity, the data logger supports a variety of external temperature and humidity sensors.

Ideal for the life sciences, food & beverag...

Emerald can be used as mobile data logger with programmable alarm limits and on-board memory for up to 16,000 readings, or as a wireless sensor paired with a Cobalt X data logger. For monitoring on the move, you can collect data at any time with the OCEAView™ Mobile app and forward it to the OCEAView web p...

With its tiny footprint, Atlas fits inside packaging yet features temperature, relative humidity, and light sensors. Atlas can be used as a data logger with programmable alarm limits for mobile monitoring or as a wireless sensor paired with a Cobalt X data logger.

Sarjen Systems’ QEdge is an enterprise-wide Quality Management System (QMS) specifically designed for pharmaceutical manufacturing. This risk-based QMS offers a comprehensive suite of solutions, including:
• Process Control • Document Control & Issuance • Training Management System • Ve...

eCOA / ePRO solution for engaging data collection
- Collect data On your hand -  MediLake eCOA/ePRO is an integrated solution for smart, rapid data collection. Subjects can report their data on their smartphone, tablet or computer via MediLake eCOA/ePRO
-...

All your trial data in one effortless solution

- Let's keep it simple , No prior skills needed - MediLake EDC features a design configuration interface seamlessly integrated into clinical data collection design, allowing y...

Our expertise lies in providing innovative solutions to drive digital transformation, fostering innovation and sustainable growth through strategic insight and collaborative partnerships.