eRA 2019 is supported by:
Agatha, Inc. is a leading strategic software solutions provider to the health care and life sciences industry. Agatha is dedicated to helping the world’s Hospitals, biotechnology, pharmaceutical, contract research organizations and medical device firms optimize the management of their Quality and Clinical documentation and processes.
Agatha solutions are immediately available online, and compliant with applicable regulations (such as FDA 21 CFR part 11). Agatha’s clients are typically up and running in a few hours, and reduce the time spent to manage their clinical and quality documentation by 80%. Agatha is therefore the trusted partner of more than 100 hospitals, research centers, CROs, pharmaceutical companies and medical device companies worldwide.
Asphalion is an international Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid and Munich. We collaborate with Pharma and Biotech companies facilitating Drug Development and Regulatory Affairs projects for Drugs, Biologics, Biosimilars, ATMPs and Medical Devices.
Our involvement ranges from early development, through to registration and post-commercialization phases. Since the company was founded in 2000, we have consistently grown and now have a team of over 80 employees with backgrounds in all areas of life sciences. Our consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards. We provide global services and work for hundreds of clients from around the world. Through collaborations with partners in all other continents, we can accelerate your worldwide scientific and regulatory activities by using local expertise.
Generis is the leader in Intelligent Content Services. Its product CARA is the leading solution providing data and content solutions to 8/ 10 of the largest life sciences companies. CARA works across multiple data sources and repositories to provide users all the data and documentation they need in a quick and efficient manner, allowing users to focus on their work not trying to find documents and data.
The CARA user interface is intuitive, easily configurable and customisable, without loss of performance. It has configurations for life sciences (end to end: including GxP/SOP/ Quality documents and Clinical Master File documentation), RIM, Human Resources and Legal Documentation.
Epista Life Science
Epista Life Science is a consultancy dedicated to continuously improving regulatory compliance. We turn compliance obstacles into business opportunities for our clients and for the industry.
We pioneer new methodologies and technologies to keep companies compliant with new and constantly evolving governmental regulations and industry trends. And we help our clients bridge the gap between QA, IT and Line-of-Business departments by aligning compliance across projects, systems and organizations. We know this makes an impact because we benchmark each and every service we provide. We use this information to pragmatically set the appropriate level of compliance for each individual customer.
Inpharmatis provides full pharmaceutical product life-cycle management over the whole of EU & CIS in pharmacovigilance, regulatory affairs, medical writing, GMP, GDP, GxP audits, market access services and a range of specific software to pharmaceutical industry.
Inpharmatis has grown from a small home-based consulting business to a global team of experts operating across Europe and CIS regions, boasting the coverage, the linguistics, and in-depth understanding of local requirements. We are offering global coverage with the local competence.
ValGenesis, Inc. provides a software solution which is the foundation for managing compliance-based validation. It is the first enterprise application to handle the corporate validation lifecycle process. ValGenesis Validation Lifecycle Management System (VLMS) is an end-to-end solution for running paperless validation while increasing efficiency and reducing costs. ValGenesis VLMS lets users re-use data and protocols across sites, facilitating ease of standardization and harmonization. It is an easily configurable solution that is available both on-premise as well as a validated SaaS. Designed specifically for life sciences, it fully automates validation and integrates directly with the equipment.
For more information, visit www.valgenesis.com
Veeva Systems Inc. is a leader in cloud based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 650 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America.
For more information, visit www.veeva.com/eu
EXTEDO - eRA Founder
EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and are the only vendor that provides solutions covering the entire regulatory landscape.
Our EXTEDOsuite combines innovation with compliance, and quality with usability. Whether planning & tracking, product registration, submission publishing and lifecycle management, pharmacovigilance management and drug safety; we optimize every eRegulatory business process.
Today, EXTEDO enables more than 35 regulatory authorities and over 850 maintained customers across 60 countries to deliver Effortless Compliance™.
For more information visit www.extedo.com.