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Matrix Req is a global software leader helping innovative Medical Device companies remain focused on developing safer products faster. MatrixALM & MatrixQMS reduce the regulatory burden by bridging the gap between agile & compliance to ensure quality across the entire product lifecycle. Matrix Req is an EN ISO 13485:2016 and ISO/IEC 27001:2013 certified company. Visit www.matrixreq.com for information.
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ACTO is an AI-powered SaaS platform built for life sciences that uses mobile experiences and agency partnerships to give learners all the right tools in one intuitive cross-platform app, and give leaders powerful admin tools with engagement data in one command center.
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SciLeads provides a visionary lead generation and market intelligence platform that helps scientific companies identify, engage with, and close their ideal buyers. With a proprietary algorithm and adoption of cutting edge technologies, SciLeads has created a database that maps the world's research output, helping sales and marketing teams quickly identify potential customers. SciLeads has brought a new approach to the life science industry in data management and the forward-thinking technology is disrupting lead generation within the life sciences industry.
Verifarma T&T Cloud is a global leader in the Pharma Serialization and Track & Trace space. With more than 2000 customers worldwide, we cover most serialization regulations around the globe.
Advarra eReg is a secure, paperless electronic Investigator Site File (eISF) system that integrates with Advarra's CTMSs--OnCore and Clinical Conductor. This centralized document management solution helps research sites improve productivity, accelerate study startup, and strengthen regulatory compliance through features such as streamlined document routing, real-time alerts for new documents, and electronic signature capabilities via Advarra eConsent. In addition to CTMS integration, Advarra eReg connects with Advarra’s CIRBI system, and internal site email systems to create a fully integrated research ecosystem. For sites transitioning to eReg, Advarra offers automated document migration, ensuring a seamless transfer of existing files and enabling immediate value from its connected technology platform.
AmpleLogic Annual Product Quality Review (APQR) Software is a web and cloud based application that eliminates the need for a paper based documentation required for review of every batch product manufactured
Life Sciences companies include Pharmaceutical, Contract Development and Manufacturing Organization (CDMO), Biotechnology, Contract Research Organization (CRO) and Biosimilars continue to operate in a highly competitive environment. The Quality Control (QC) laboratory in a pharmaceutical company plays a critical role in the testing of Raw Materials, Stability, In-process and FG Samples. QC Analysts from different sections analyze incoming samples of different kinds. These include Finished Goods (FG), in-process products, stability samples, and environmental samples. Analysts may also be required to analyze raw materials. In organizations with diversified drug products, the number of samples to be tested per week will range from 150 – 400 Samples and each sample must go through a minimum of 6 tests. In such a scenario it is a challenge to prioritize the samples and assign equipment like HPLC/GC to the QC Analyst manually. HOD’s of QC Labs are under steady pressure to improve the lab operations in order to meet the Sample TAT (Turn Around Time). The equipment used in the Pharmaceutical and Biotech product testing are highly sophisticated, extremely sensitive, and very expensive. Maximizing both staff (Laboratory technicians and managers) time and machine time is essential in the QC lab to address the problems of varying demands and to maximize resource efficiency. Consequently, Planners/Managers are finding a way to move towards lean QC lab by improving their processes, improving effective utilization of resources, reducing lead times, and at the same time, increasing reliability by accelerating authorization processes for compliance. This affects both production and batch release. A good Quality Control Planning describes how an organization will achieve its quality goals by specifying the quality assurance and control activities which are performed as part of daily lab operations