Sponsors
Gold Sponsor:
ABOUT EXTEDO - IABG Life Sciences Solutions GmbH
For more than a decade, EXTEDO - IABG-LSS (www.iabg-lss.com) has been working in the field of data and document
management for Life Sciences Solutions. On the basis of well-founded expertise and the many years experience
EXTEDO - IABG-LSS provides integral and customized solutions to regulatory affairs, scientific/technical and
economic/organizational problems.
In our focus on the Life Sciences Industries, we provide services and solutions in the fields of:
EXTEDO - IABG-LSS accompanies all implementation and integration projects with additional added value services such as business consultancy, quality assurance, training, change and project management. EXTEDO - IABG-LSS is the producer of the standard software products eCTDmanager and EURS is Yours. EXTEDO - IABG-LSS is a recognized leader in the e-Regulatory Affairs domain. EXTEDO - IABG-LSS has defined the open standard CADDY-xml for the electronic submission of Crop Sciences applications to support the mission of the ECPA (European Crop Protection Association). EXTEDO - IABG-LSS is the single operator of the EURS system at EMEA and various associated NCAs for the electronic approval of drug applications in Europe. EXTEDO - IABG-LSS is providing OTC products for the verification of technical documents for structural compliance and long term archival (DOCvalidator), drug safety (PcVmanager) and electronic management of product data and associated electronic labelling documents based on PIM, SPL and beyond (PImanager).
Silver Sponsor:
ABOUT DATAFARM, Inc.
Datafarm is a leading solutions provider of Electronic Document Publishing and Regulatory Submissions Services for the
Life Sciences Industry. Datafarm augments the drug development process by providing both custom and off-the-shelf
regulatory compliant solutions worldwide. Datafarm solutions, delivered through its products and professional services,
maximize the quality of publishing and efficiency of document life-cycle management. To date, Datafarm has assisted
sponsor organizations with over 300 electronic submissions, submitted to the FDA, Health Canada, EMEA and Japan
regulatory authorities.
ABOUT OPTIMAL SYSTEMS GmbH
Since 2006, Optimal Systems GmbH Bielefeld has positioned itself in the area of life sciences with eDMS solutions (electronic Document Management System). As a subsidiary of Optimal Systems GmbH Berlin, which has been in operation for 16 years, the company has a good stock of employees with a broad range of experience in the sector and provides innovative, proven technologies.
OS.5|ECM is a user-friendly standard product that enables Optimal Systems to prepare for the growing demands of the pharmaceutical industry. Particular emphasis is placed on business process optimization and safe management of all data and documents to a particularly high standard of quality. Optimal Systems GmbH Bielefeld is thus the ideal partner for the future-oriented consulting, planning and implementation of eDMS projects in the regulatory environment.
Long-term installations for public authorities and within the pharmaceutical industry bear witness to the company’s market competence. Local branches throughout Germany and a comprehensive network of well-known partners give the company the necessary flexibility and proximity to its customers.
ABOUT e-SubmissionsSolutions.com
e-SubmissionsSolutions.com (a California corporation) was founded by Antoinette Azevedo in 2000 to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Clients range from large, international pharmaceutical companies to small, virtual biotechnology companies - all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations.
www.e-SubmissionsSolutions.com
ABOUT QUMAS
With over a decade of experience, QUMAS is the only global compliance software company offering a complete solution to regulated industries. Recognised as the world leader in Enterprise Compliance, Governance and Risk Management, the company has over 250 customer deployments including global leaders such as Fidelity Investments.
QUMAS is the only vendor that offers a suite of products that enables companies in financial services, life sciences and other regulated industries to achieve complete, enterprise-wide compliance with a broad range of regulations and initiatives.
QUMAS provides highly configurable applications, ready for validation and deployment within regulated environments. Based on open systems platforms, QUMAS technology integrates seamlessly with existing corporate database, applications, operating systems and hardware from most major vendors.
ABOUT SDL International
SDL International is the leader in Global Information Management (GIM) solutions that empower organizations to accelerate the delivery of high-quality multilingual content to global markets. Its enterprise software and services integrate with existing business systems to manage global information from authoring to publication and throughout the distributed translation supply chain.
