Exhibitor Profiles
This year’s Symposium once again features an exhibition alongside the sessions. There are 21 organisations exhibiting alongside stands from TOPRA, the Medical Products Agency, Sweden and the Medical Technologies Regulator Affairs MSc from Cranfield University. Below you will find exhibitor profiles of all 21 organisations as well as a floorplan so you can plan your visit to the exhibition.
Stand 1 - Sofus
Sofus is specialized in Regulatory Affairs since 2002. No matter if you're a multinational corporation or a small business - together we can help you shorten the distance between your product and the patient.
Our flexible consultancy services and hands-on knowledge of the Nordic conditions combine to ease your operative regulatory needs. We offer a wide range of services, from complete solutions to single projects. From regulatory strategies to simple filing procedures.
More than 100 clients from all parts of the world have proven us right. Read more at www.sofus.se.
Stand 2 - Extedo
EXTEDO is a key services and solutions provider in the field of regulatory data and document management for Life
Sciences industries and authorities (Pharmaceuticals, Medical Devices, Crop Science):
- Registration Management
- Submission Management (eCTD)
- Product Information and Labeling Management (PIM/SPL)
- Pharmacovigilance Management (E2B)
- Document /Content Management
- Project Management
EXTEDO being globally represented serves more than 600 Life Sciences organizations in more than 50 countries.
Stand 3 - Regulatory Pharma Net (RPN)
Regulatory Pharma Net (RPN) is a private limited company providing consultancy to Pharmaceutical Industry. RPN offers full regulatory affairs consultancy services (e.g. national and European registration procedures, Orphan Designation & Scientific Advice Applications, preparation of registration dossier in CTD and eCTD format).
Stand 4 – Thomson Reuters
Thomson Reuters is the leading source of intelligent information for life sciences professionals around the world. Our content, tools and services are essential for drug companies to discover new drugs and get them to market faster, for researchers to find relevant papers and know what’s newly published in their subject, and for businesses to optimize their intellectual property and find competitive intelligence. These solutions include the world’s largest single collection of regulatory affairs reference texts IDRAC(r), Liquent InSight(r), the award winning drug discovery and development portal Thomson Pharma(r), Prous Science Integrity(r), and the pioneering biomarker database BIOMARKERcenter.
Stand 5 – LORENZ
LORENZ is the most established provider of e-regulatory software and services in the world. LORENZ has focused on bringing intuitive, business-driven solutions to the market. As an innovative software engineering company, LORENZ’ solutions foster independence, empowering customers to develop their processes and maintain control of their own intellectual property.
Stand 6 – ISI
Founded in 1992, Image Solutions, Inc. (ISI), is a proven market leader in providing submission solutions, process services, and consulting for life sciences companies as a way to improve regulatory processes that bring new medicines to market. For more information, visit the company’s Web site at www.imagesolutions.com.
Stand 7 – ProClinical
ProClinical is a specialist Pharmaceutical recruitment agency covering Executive Search as well as permanent and contract recruitment across Europe. Our scientifically qualified recruiters work with clients and candidates in the areas of
Regulatory Affairs, Clinical Research, Drug Safety, Medical Affairs, Health Economics, Quality Assurance and other R&D roles.
Stand 8 – Merrill Brink International
Merrill Brink International is a leading provider of specialist translation services to CROs, regulatory consultants, pharmaceutical and biotechnology companies. We are one of the few language service providers in the world to be certified to ISO 9001:2000 and ISO 13485:2003 and registered to ISO14971:2007. Together, these standards provide assurance that the most stringent process and quality standards for translation are followed. Our rapid turnaround times help streamline the translation of clinical research, regulatory submission and review, production or marketing documents to expedite your new drug's all-important time-to-market.
Visit us at stand number 8 for a language consultation.
Email: gerry.lynch@merrillbrink.com
Tel: +353 (0)91 782911
www.merrillbrink.com/lifesciences
Merrill Brink International
Unit 2B, Ballybrit Business Park
Galway, Ireland
Stand 9 – DWL
DWL – the specialist translation service provider for the pharmaceutical industry. Translations for regulatory affairs; clinical trials, legal documentation and medical research. Into and from all EU and many other languages. For further details contact:
Samuel J. Wirth, Managing Director,
by phone on +44 (0)20 7229 4552 or
e-mail s.j.wirth@dwlanguages.com
Stand 10 – NDA
NDA is one of the leading European Regulatory consultancies in Europe, with offices in Sweden, UK & Germany. We provide high quality support and professional advice in all aspects of Regulatory Affairs, with expertise in Pharmacovigilance & Drug safety, Quality Assurance, Readability, Biopharmaceuticals, Paediatrics, Electronic publishing, Training and the unique guidance of the NDA Advisory Board
Stand 11 – Axess
AXESS have been developing careers within Regulatory Affairs since 1990. Increased resource has further strengthened our expertise, developed our client portfolio and led to even greater success in placing and advising candidates from Regulatory Officer to Senior Director, covering R&D, CMC and Marketed Products for UK ,European & Global roles.
AXESS Ltd, Parkshot House, 5 Kew
Road, Richmond, Surrey TW9 2PR
Tel: 020 8560 2300
Email: paul.foster@axess.co.uk
Stand 12 – Datafarm
Datafarm is a world leader in high performance electronic regulatory submission solutions to the Life Sciences industries. Datafarm’s software and professional services enable Life Sciences companies to meet the strict standards of global regulatory authorities, helping them achieve quality, accuracy, and compliance to efficiently deliver regulatory reports and submissions
Stand 13 – ArisGlobal
For over 20 years, ArisGlobal has been a trusted and reliable partner of many of the world's leading pharmaceutical, device, biotechnology andclinical research organizations. More than 150 life science customers rely on our innovation and advanced technology solutions in pharmacovigilance & safety, regulatory affairs, clinical research and medical information.
Stand 14 – Pharmalink Consulting
Pharmalink Consulting has experienced rapid growth for over a decade, expanding into every major geography to become the world's largest independent RA specialists. Pharmalink works with equal success in partnership with large multi-nationals, small start-ups, biotechs, CROs and device manufacturers. Our success lies in a straightforward, transparent approach combined with Regulatory experience of unrivalled depth.
Stand 15 – CSC
CSC offers enterprise content management and collaboration products and services on the Microsoft (FirstPoint) and
Documentum (FirstDoc) platforms. Our solutions help companies manage the proliferation of enterprise content, improve timely regulatory reporting, and enable secure partner collaboration while minimizing the risk of non-compliance.
Stand 16 – TransPerfect
TransPerfect is the world's only major language services provider fully certified to ISO 9001:2000 and EN 15038:2006. That's why the world's major life sciences companies rely on us to help them successfully submit their regulatory applications for approval by local authorities and ethics committees. TransPerfect provides full multilingual PIM/SPL support, and our collaborative technology, Trial Interactive, offers an automated solution to facilitate eCTD document organisation.
Stand 17 – TranScrip Partners LLP
TranScrip Partners LLP is a firm of highly skilled, very experienced pharmaceutical medical/scientific professionals, with expertise in drug development/commercialisation (plus KOLs as Senior Academic Partners) with absolute commitment to project delivery. Expertise covers most sub-disciplines (safety, risk management, regulatory, clinical development and programme leadership (Phase 0-IV)) and multiple TAs.
Stand 18 – emedcareers.com
emedcareers.com is the place to find the latest Regulatory Affairs jobs in the Biotechnology, Pharmaceutical and Healthcare industries. Simply register for job alerts and we’ll send you the latest jobs by email every day. Why not also upload your CV as searchable and let employers approach you with suitable jobs?
Stand 19 – Medifact
With unrivalled scientific leadership and offices in the US, Europe, and Asia, Medifacts provides a full range of high-quality cardiovascular safety, efficacy, consultancy, and analysis services. Medifacts'services include 12-lead ECG and Holter; Automated Office, Home, and Ambulatory Blood Pressure Monitoring; Diagnostic Telemonitoring; Glucose Monitoring; and Pulse Wave Analysis.
Stand 20 – i3
i3, the company of specialists. We offer better people, better data, and better processes that bring our customers better results. We understand that every stage in clinical product development and commercialization represent opportunities to impact performance and improve quality.
Visit www.i3global.com
Stand 21 – Tarius
Tarius® Web Portals provides easy access to global regulatory FAQ’s and national authorities’ regulations. Your customized web portal consolidates your choice of Medical Device, IVD, Human Drugs and Biologics information from 60+ countries into a single, searchable interface with “Google-like” functionality providing immediate access to business-critical regulatory information – updated daily.
Contact: Eva L. Petersen
Email: elp@tarius.com
Web: www.tarius.com
Floorplan
