eRA 2019 is supported by:

AGATHA

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. 

en.agathalife.com

ASPHALION

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.

www.asphalion.com 

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.

www.epista.com 

Veeva Systems

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.