Product Listings
Ennov, an independent cloud software vendor, proposes a regulated content management platform, and five solution sets built on top of this platform, each tailored for the Life Sciences sector. These are Quality Management, Regulatory Compliance, Clinical Trial Management, Pharmacovigilance system, and Pharmaceutical Event Management. These tools assist organizations in complying with internal and regulatory standards. The Ennov platform features built-in electronic signature and audit trail, LDAP synchronization, and connectors. Despite being generally deployed as a cloud solution, the Ennov platform can also be installed on-premises.
Appian is a software company that automates business processes. The Appian AI Process Platform includes everything you need to design, automate, and optimize even the most complex processes, from start to finish. The world's most innovative organizations trust Appian to improve their workflows, unify data, and optimize operations—resulting in better growth and superior customer experiences.
Generis focuses on providing CARA, an enterprise cloud solution that enables effective data, content, and business process management. The chief aim of the company is to solve the critical business problem of comprehensive and seamless data and process management across sectors.
OpenText powers and protects information to elevate every person and every organization to gain the information advantage. As a global Information Management company, OpenText offers a portfolio of solutions across content, business network, digital experience, security, application modernization, operations management and developer APIs. OpenText solutions help customers simplify their systems, connect their data, build frictionless automation and thrive in a multi-cloud world. The company fosters inclusive environments that leverage the diverse backgrounds and perspectives of all employees, customers, suppliers and partners.
Kalypso is a company that assists in transforming client approaches to product development and operations by integrating a digital value chain. This impacts all stages of a product's lifecycle, starting from conceptualization, execution to reaching the final consumer. The main services Kalypso offers encompass strategy and change management, enterprise technology, along with data science and artificial intelligence. The team at Kalypso comprises individuals with profound understanding and experience in various industries such as discrete, hybrid and process, and they serve a global clientele.
Amplexor is a digital solution provider that specializes in global compliance, digital experience and content solutions. The company focuses on assisting its customers to enhance process efficiency, maximize revenue generation, minimize time-to-market and guarantee quality and compliance. The primary services include software technology, consulting, system integration, and language and content management. Amplexor operates in numerous sectors such as aerospace, defence and transport, energy and environment, finance, life sciences, manufacturing, and the public sector in 23 countries worldwide.
Calyx is a company that predominantly operates in the medical field, providing advanced eClinical solutions and services. Its key focus is on the development of innovative medical treatments and expediting their entry into the market. The company brings over 25 years of experience in clinical development, having consistently aided trial sponsors and clinical research organizations. By leveraging its in-depth knowledge and turning it into actionable intelligence, Calyx helps tackle complex issues and offers quick insights, thereby facilitating daily advancements in the medical drug market. The company's services include Medical Imaging, IRT, CTMS, EDC, and RIM.
EXTEDO is a solutions and services provider specializing in Regulatory Information Management (RIM). The company's focus is on enhancing eRegulatory business processes of its clients. EXTEDO offers a range of solutions that address various aspects of the regulatory landscape, including Document Management, Planning & Tracking, Product Registration, Submission Management, and Pharmacovigilance Management and Drug Safety. These solutions are designed to facilitate regulatory compliance in a more effortless manner. The company serves regulatory authorities and maintained customers across multiple countries and industries, such as biotechnology, homeopathics, medical devices, and crop sciences. Through the mission of Effortless Compliance, EXTEDO aims to allow organizations to devote more time to tasks they want to accomplish instead of those they are required to fulfill.
ArisGlobal is a firm in the life sciences sector that focuses on enhancing the process through which life science companies develop novel breakthroughs and launch new products. Its principal offering is an end-to-end drug development technology platform referred to as LifeSphere. This integrates their unique cognitive computing engine to fully automate essential drug development tasks. Informed by nearly four decades of experience and a long-term perspective, LifeSphere is designed to improve efficiency, assure compliance, and decrease cost through multi-tenant Software-as-a-Service (SaaS) structure. ArisGlobal's main office is located in Waltham, MA, with additional regional offices in Europe, India, Japan, and China.
With MasterControl quality management system (QMS) and manufacturing execution system (MES) software, you never have to sacrifice compliance to achieve efficiency. Our solutions are designed to ensure compliance with regulatory requirements while also increasing operational efficiency. By natively connecting quality and manufacturing data in one powerful digital tool, MasterControl enhances data connectivity and provides real-time visibility into processes across the entire life cycle of your regulated products. Over 1,100 companies worldwide use MasterControl solutions to streamline operations, maintain compliance, easily analyze and interpret large amounts of data, and visualize business insights in real time.
Biomedion is a software enterprise headquartered in Germany, primarily involved in developing cloud-based solutions tailored for the life sciences sector. The business launched a key product named neuronOS in 2020. This data-centric platform for the life sciences industry offers enhanced security and customization, focusing on data integrity and ensuring all-round compliance in a pharmaceutical environment. The platform is designed to aid GDPR readiness, providing the validation required for computerized systems. It abides by the compliance requirements stipulated in 21 CFR Part 11. The firm offers ready-to-use applications to match the demands of quality, clinical, and regulatory procedures, including numerous integrations compatible with existing enterprise applications. Since commencing operations in 2014, Biomedion has developed a range of adaptable data-driven offerings for the life sciences sphere that deal with all stages from raw data and quality to retention and archiving.
Phlexglobal is a technology and services company specializing in clinical and regulatory matters. The firm aids businesses in mastering their digitization goals using established artificial intelligence solutions. The company features an amalgamation of software and expertise to provide a unique array of solutions offering smooth automation via data generation to enhance corporate effectiveness. Phlexglobal's software offerings include PhlexTMF, a Trial Master File software, and a suite of regulatory solutions such as PhlexSubmission for eCTD and CTD, PhlexIDMP, PhlexEVMPD, and PhlexRIM. Another service offered is PhlexNeuron, a machine learning platform designed to read documents and translate unstructured content into structured data, thereby streamlining regulatory and clinical processes. Phlexglobal is part of the PharmaLex Group conglomerate.
Sarjen Systems is a seasoned provider of digital transformation and automation solutions with a track record spanning over two decades. The company's main area of focus lies in developing a variety of software tailored to meet specific industry requirements. These industries span pharmaceutical, life science, healthcare, FMCG, and more. Included in Sarjen System's repertoire of software are solutions for drug safety, clinical trial management, dossier compilation, product regulatory information, quality management systems, and smart manufacturing solutions. Additionally, Sarjen Systems also offers consulting services in hyperautomation, eCTD, and publishing. These broad range of offerings underscore the company's dedication to fostering digital transformation across multifarious sectors.
Montrium primarily specializes in delivering cloud-based solutions such as records, submissions, quality management, and GxP consulting for the life sciences industry. The company aims to help organizations leverage technology to streamline processes and ensure compliance. Montrium excels in configuring custom-made solutions that address exact client needs. The dynamic team at Montrium values collaboration, and is committed to prioritizing customers' interests. One of Montrium's notable principles is pursuing all ventures in a transparent manner, thus fostering dependable relationships within the life sciences arena. Its product suite encompasses software like Electronic Trial Master File Software, Regulatory Document Management System, and Quality Management System. Additionally, Montrium's services extend from Cloud Strategy, Cloud Compliance and Qualification Services, Office 365 Configuration and Strategy, to Computer System Validation and Quality Assurance.
Orion Governance Inc. Founded in 2017 is a Silicon Valley-based company. Our platform the Enterprise Information Intelligence Graph (EIIG) is a Knowledge Graph that supports Metadata Management and Governance by leveraging Generative AI, AI/ML and automation. The out of the box support for ingesting metadata from 70+ technologies and automatically interconnecting them, provides horizontal and vertical/business lineage, near real-time impact analysis/alerting and propagation of Data Quality, Code Quality and other active metadata. It is a no-code platform that operates on-premises, in the cloud or can be provisioned as a PaaS (Platform as a Service). Technologies supported range from Mainframe (JCL/COBOL/PL1/IMS) to Java, Scala, Python and Javascript. Besides this all SQL databases, most NoSQL databases, reporting tools, shell scripts and enterprise schedulers are also supported out of the box. The company operates in the Americas, Europe, India and Singapore.
AmpleLogic is a provider of Low Code No Code (LCNC) Solutions with a specific focus on the life sciences industry. Founded in 2010, the company has designed its LCNC software development platform to assist with enhancing efficiencies in this sector. With a suite of diverse and strategic products including eQMS, LMS, DMS, eLogs, Calibration Schedules, Stability, APQR and eBMR, AmpleLogic aims to support pharma companies by equipping them with the necessary software tools. Their product, Enterprise Automation, is a GMP Quality Management System, specifically designed to help life sciences companies manage quality within a regulated environment, stemming from exhaustive research and dedication. AmpleLogic has built significant business relations globally, serving a growing number of both pharmaceutical and semiconductor companies.
Rimsys is a provider of Regulatory Information Management (RIM) software for medical technology companies. This tool offers a consolidated platform for all regulatory affairs functions, including product registration, standards management, essential principles/GSPR, regulatory submissions, post market surveillance and regulatory intelligence. Designed specifically for medical technology sector, Rimsys aids regulatory affairs professionals in digitizing, automating, and navigating global regulatory landscapes.
Instem is a company that supplies IT applications primarily focused on the early development healthcare market. It aims to assist life science and healthcare organizations in making data-driven decisions by providing solutions for data collection, management, and analysis. Instem's range of software solutions elevates customer productivity by mechanizing study-related procedures, offering unique capabilities to produce new knowledge via the extraction and harmonizing of actionable scientific data. The company ensures support for its clients globally, maintaining fully-serviced offices in different countries including United States, United Kingdom, China, India and also through a distributor in Japan.
Intagras operates primarily in the global pharmaceutical industry, delivering a comprehensive range of enterprise-level regulatory software solutions. These advanced applications offer significant return on investment. The company utilizes its extensive industry knowledge and experience for every task. It occupies a significant space among pharmaceutical software companies and bases its success solely on the success of its legal conditions.