CSV - Computer Systems Validation

Midas Pharma offers a wide range of pharmaceutical services which includes finished product manufacturing services. Midas offers a complete package - from API sourcing and technology transfer to variation filing - or just the modular services you require.This includes: • identification and qualif...

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...

From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...

Elexy™ is a versatile, electromechanical autoinjector that features a reusable power unit compatible with drug cassettes containing a pre-filled syringe or a cartridge. Its versatility enables a wider choice of intended injection profiles, including drug volume, drug viscosity, and injection speed. In ...

ManageArtworks is a cloud-based packaging and artwork life cycle management system. It connects people and processes across internal departments, stakeholders, customers, suppliers, agencies, and vendors to get products faster to the market while meeting regulatory compliance. We warranty a s...

Darwin, the Machine Performance Finder, offers various intelligent features to identify concrete optimization potentials of an automated machine. In this way, it significantly increases the performance level of the machines.



The Machine Benchmark learns a virtual ideal process on the basis ...

ColdStream® Site Stationary Monitoring is a wireless solution that automates monitoring of temperature, humidity and condition of controlled environments for life sciences manufacturing, packaging/repackaging, laboratories, clinical pharmacies, retail pharmacies, incubators, wholesalers, distributers, an...

Cortellis Product Intelligence is a comprehensive source of global drug, market, API, and patent data that helps innovators, CDMOs, generics and API manufacturers grow their business and build robust supply chains.

PeP11 LabCal offers a Single Validation SaaS Solution Platform that manages all Excel spreadsheets, eliminating the need for individual validations. This comprehensive electronic Excel solution features an Electronic Signature, Audit Trail, and Role-Based Access, rendering paper signatures unnecessary ...

Distributed Control & Data Management System is our design approach to bring all the automated systems in plant on a single platform with an operational and Database redundancy. It is an application that helps clients to secure and store the data in system as per their IT policy. The key objectives of ...

INOSIM is a flexible process simulation tool capable of handling even the most complex of production processes. Quickly perform virtual experiments in our powerful simulation suite to obtain quantifiable and qualitative data to guide your important decisions. We are offering the three simulation environmen...

The Clinvigilant eClinical suite includes: EDC, eCRF, eTMF, eSource, IWRS, ePRO, eConsent and eCOA. Just pick the tools that you need and we will integrate them with your existing software ecosystem.

Clinvigilant is a global cost-effective eClinical tools provider for Pharma, Biot...

SLIMStat is extremely easy-to-use software developed and validated specifically to determine the shelf life of drug products that have been placed on stability. This interactive and intuitive tool empowers non-statisticians the ability to generate statistical analyses with complete confidence. Fully v...

A hardware independent SCADA software provides limitless analytics and reporting needs with built in historian. Very Popular for 21CFR11 Compliance in Pharma industry

Straight complete inspection of small size full vials based on the HEUFT SPECTRUM II. Full equipment and automation for maximum detection reliability in an efficient and space-saving straight-through system:  the HEUFT spotter II PHS n...

BIOVIA Discoverant is a validation-ready solution for data access, automated aggregation and contextualization, analysis and reporting. It supports Industry 4.0 strategies by optimizing processes, product quality and yield and collaboration, delivering products and therapeutics faster and at lower cos...

AI-enabled, cloud-ready,360 pharmacovigilance solution for safety database management. An end-to-end globally compliant safety software for Drugs, Devices, Vaccines and Combinational products from case intake to submissions and reporting. • Case Intake • Case Processing • Case Submission • Risk Manage...

At ApiJect, our experts design proprietary injection systems that allow partners to deliver their drug products using cost-effective Blow-Fill-Seal (BFS) manufacturing technology. Our first designed device is the Prefilled ApiJect Injector*: a proprietary, sterile, unit-dose injection system that is market...

Designed for the Pharmaceutical Industry.Give your Sales team and ease to manage their daily routine, plan their activities, and effectively communicate with help of digital media.

Vision SFA modules include AI based reporting, eDetailing, Expense management, Survey and feedbacks, Learning ...

The BIAZZI's High Performance Reactor System is characterised by a high heat removal capacity, efficient mixing and a high internal gas recirculation rate. The benefits are higher productivity (smaller units), reduced consumptions, higher product yields and better product quality. Over all the operational ...

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

Ignition SCADA by Inductive Automation® offers a modern, open platform for supervisory control and data acquisition, addressing the common challenges of traditional SCADA systems. With its unlimited licensing model, web-based deployment, and powerful toolset, Ignition makes it easy to control processes and...

Utopia Optovision Pvt Ltd, as a Complete Solution Provider in the field of TIJ Coding, Machine Vision and Track and Trace for Pharmaceutical Industry.

 

Please find attachment for Track & Trace Brochure and Presentation.

 

...

InSyBio Suite is a SaaS cloud based-platform and consists of tools for providing integrated biological information from various sources, while at the same time is empowered with robust, user-friendly and installation-free bioinformatics tools based on AI, machine learning, statistical and network algorithm...

We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...

as per gWegovy for Semaglutide injection

VetaFilm™ is our proprietary veterinary oral film technology that provides significant market opportunities to improve drug delivery for companion animals. VetaFilm™ research and development services and veterinary oral films provide: • Dose placed directly on oral mucosa or on their f...

Levosimendan indicated for short-term treatment of acutely decompensated severe chronic heart failure. Form & strength: 2.5mg/ml concentrate for solution for infusion 

A personalized interactive preventive healthcare interface
B Next CARE uses artificial intelligence to integrate the most recent medical knowledge:
- to interpret the results of analysis
- to understand and monitor vital signs
- to calculate and evaluate a score for the patients’ physical and m...

Our STARMAP® 2.0 platform leverages cutting-edge sparse-data AI to pick winners among candidate molecules that are predicted to be best amenable to CESS®-powered nanoforming and that exhibit optimal production characteristics.

When existing data alone is not sufficient for generating specific pr...

Beyond lab data management, STARLIMS is a comprehensive solution that improves quality and safety throughout the entire product lifecycle. Configurable features help laboratories from sample intake to delivery of accurate results, driving smarter decision making for your business and customers throug...

Drawing on its experience in the management of major pharmaceutical projects, ZETA offers new digitalisation strategies, which reduce complexity by effectively using digital process data.

Based on its established engineering toolchain, ZETA offers SMART ENGINEERING SERVICES (SES) to integrate al...

XpertMods is an award-winning digital platform to accelerate the medical teaching and learning :
Therapeutic Patient Education - Clinical Research - Complex Solutions Consulting ...
We propose an additional modular service offer to accelerate your teaching and learning program   qq...

INOSIM is a flexible process simulation tool capable of handling even the most complex of production processes. Quickly perform virtual experiments in our powerful simulation suite to obtain quantifiable and qualitative data to guide your important decisions. We are offering the three simulation environmen...

ST Pharm provides mRNA CDMO service from custom mRNA IVT synthesis to lipid nanoparticle (LNP) formulation with its own IP on two key mRNA platform technologies, SmartCap (proprietary 5'-capping) and STLNP (LNP with novel ionizable lipid). We are able to manufacture in GMP/non-GMP grade, and able to suppo...

Biostat STR® single-use bioreactors and the Biobrain® automation platform are engineered to allow you to rapidly adapt your biomanufacturing facility to address changing requirements by offering multiple configurations and convenient software upgrades. The generation 3 system is now available wit...

Multibox TE is a compact labelling system for serialization on pharma product, top-down label application and tamper evident labelling.It is the most compact and versatile system to run at up to 300 products per minute in length of 1200 mm. This solution includes printing, inspection, tamper evident applic...

 See https://www.medlab.group/what-is-nanocelle

NanoCelle can be deployed in many molecules to enhance absorption, and increase patient compliance whilst reducing side effects.

CMO Intelligence: Synchronise data between production, supply and planning.
Veratrak’s CMO Intelligence solution collates and synchronises manufacturing, quality and commercial data between production, supply, planning and change management systems to achieve a fully integrated view of manufacturing...

Service Overview Drug Development and Manufacturing • Development of solid, semi-solid and liquid formulations for oral, topical, nasal and parenteral application
• API characterisation and quality screening • Small batch manufacturing §Clinical trial batch manufacturing and distributio...

The Aseptsoft add-on developed by Aseptconn was designed to increase efficiency in pharmaceutical process design many times over. Save a lot of time, money and idle time.

Say goodbye to the hassle of manual paperwork and drawings with AseptSoft®. With just a click, this innovative softwar...

rfxcel’s Integrated Monitoring (rIM) solution, powered by Internet of Things (IoT) technologies, gathers real-time data to help streamline your supply chain, improve delivery, and address compliance requirements by remotely monitoring your critical assets. With rIM, you can track any data point and never ...

Arvato Systems has been officially named as National Blueprint Service Provider by the European Medicines Verification Organization (EMVO).

In addition, as part of its comprehensive supplier evaluation, the EMVO has confirmed Arvato Systems' quality standards. All member states of the ...

DALI has developed and designed its SYNNECT smart injection solution to add innovative features to the regular syringe.
As part of the Digital Health and IoMT (Internet of Medical Things) worlds, SYNNECT utilizes sensing and connectivity technologies to offer a variety of new capabilities.
...

All-in-One Solution - MediLake SEND handles all stages of non-clinical research within a single integrated platform, streamlining the research process and maximizing efficiency.

Easy to Use,Streamlined Processes - With its intuitive interface, MediLake SEND all...

Lab Iconics ADBS is automated backup scheduling software which helps in managing the data backups and archives, in incremental, differential and full backup with encryption and log.  

AmpleLogic QMS Software automates quality processes like CAPA, Change Control, Deviation, OOS, OOT, Audit Management, Vendor Qualification in pharma and life-science manufacturing companies who do it manually. All the AmpleLogic modules are 21 CFR Part 11 and EU annexure 11 compliant. Automating QMS helps ...

Manage Your Own Forms Digitally! 
Are you still collecting data with paper forms or spreadsheets? Enable “Digital Forms” to design any form layout easily and start collecting data digitally. Integrated to OEE Tracker and Labor Tracker, use cases are endless. • Digitize maintenance or quality form...