2017 Exhibitors

Biomapas

Biomapas – a full-service CRO providing Clinical Research, Regulatory Affairs and Pharmacovigilance services. We are a team of professionals supporting Pharmaceutical, Medtech and Biotech companies for over 16 years. Our competent team provides state of the art solutions from early phase clinical development to the marketing authorization and lifecycle management.

www.biomapas.eu




BlueReg

Extedo logo

BlueReg is a consultancy company specialised in drug development, regulatory affairs, quality, scientific writing and pharmacovigilance. Our services can be tailored to meet your needs in terms of consultancy, writing, preparation, submission and maintenance of regulatory dossiers. Our flexible approach and dynamic team, with extensive industry experience, will guide you to project success.

www.bluereg-group.com




Cunesoft

Cunesoft provides a sophisticated and integrated regulatory operations solution that unifies DMS, eCTD, IDMP and RIM capabilities as well as its innovative document data mining solution purpose built for IDMP readiness.

www.cunesoft.com




DWL

Extedo logo

In house medical expertise, a proven track record of dedication to the field, and a strong commitment to quality and service all combine to make DWL your reliable partner for global life science translation solutions.

DWL has over 50 years’ experience in providing translation services and language consultancy in the following specialist areas: regulatory affairs, clinical research, medical research, medical publishing, medical devices, manufacturing, legal, and marketing communications.

www.dwlanguages.com




EXTEDO

Extedo logo

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. Today, EXTEDO enables about 35 regulatory authorities and over 700 maintained customers across 60 countries to deliver Effortless Compliance™.

www.extedo.com




Hydrogen

Hydrogen’s Life Sciences team specialise in providing experienced professionals across biometrics, quality assurance and technical operations, medical affairs, clinical operations and regulatory affairs.

As your resource provider, you can expect sharp industry insight. Placing exceptional, hard-to-find candidates is what we do best. And our understanding of the life sciences market means we’re best placed to find the right candidates for your business.

www.hydrogengroup.com




INC Research/inVentiv Health

INC Research/inVentiv Health is the only fully integrated biopharmaceutical solutions organisation. Our company, including a Contract Research Organisation (CRO) and Contract Commercial Organisation (CCO), is purpose-built to address new market realities where clinical and commercial share expertise, data and insights to accelerate biopharmaceutical performance. With more than 22,000 employees and the ability to support customers in more than 110 countries, our global scale and deep therapeutic alignment enables INC Research/inVentiv Health to help customers successfully navigate an increasingly complex environment.

incresearch.com   inventivhealth.com




LORENZ Life Sciences Group

LORENZ Life Sciences Group has an array of RIM solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services.

www.lorenz.cc




PharmaLex

Development Consulting, Regulatory Affairs, Quality Management & Compliance as well as Pharmacovigilance are our core service areas. Whether you are looking for bench-to-market guidance or are interested in maintenance activities covering entire portfolios, our worldwide teams are available when and where you need them. We provide confidence beyond compliance.

www.pharmalex.com




PleaseReview

PleaseReview logo

PleaseTech’s flagship product, PleaseReview, is a unique collaborative review, co-authoring and redaction solution for Microsoft Word, PDF and other document types. Used extensively by Life Sciences organizations, it facilitates controlled, simultaneous and secure collaboration for the production of quality compliant documents.

www.pleasetech.com/pleasereview




ProClinical

At ProClinical, we care about enabling life science companies to treat patients in areas of unmet medical need. That’s why we deliver the best people, who can make the most impact, for each individual role. Speak to a specialist in our regulatory affairs team for assistance with permanent or contract positions.

www.proclinical.com




ProductLife Group

Extedo logo

ProductLife Group specialises in helping international life sciences organisations more effectively get their products and therapies to market by providing those clients with functional support across all of the regulated stages of the product life cycle—from development to launch, to postmarketing.

www.productlifegroup.com




RegIQ Solutions

RegIQ Solutions is the world’s first automated platform providing global access to regulatory guidance and compliance information for all types and risk classes of medical devices. It’s unique design features detailed summaries on regulatory requirements in all countries requiring product registration. Its knowledge base and document manager seamlessly integrate with the platform for consolidated tracking of license information and supporting material. In addition, the Go to Market module provides snap shot information on regulatory requirements, with a single click of the mouse.

www.regiqsolutions.com




Regulatory Professionals

Regulatory Professionals, part of the Clinical Professionals Group, is Europe's leading independent life science staffing business. We are dedicated to staffing regulatory experts in the pharmaceutical, biotechnology, devices and CRO industries throughout Europe. Regulatory Professionals also covers contractors (either freelance or permanent), permanent contingency and search and selection recruitment.

www.regulatoryprofessionals.com




Regulis

Our sole focus is regulatory affairs, product safety and quality assurance for pharmaceuticals, biotechnology products, medical devices and cosmetics. From the strategic to the operational, we guide you through the regulatory maze to get your products licensed as quickly as possible, protect your patients and enhance the value of your products. Our dynamic and forward-thinking team deliver their expertise with focus, simplicity and strong commercial thinking.

www.regulis.com




Samarind RMS

Samarind is an award-winning solution provider in the life sciences industry. Samarind RMS is the benchmark for ‘the single place of truth’ in regulatory information management and beyond, supplying a single source of information for submission tracking, xEVMPD, eCTD, EDMS, ICSR reporting, medical device registration tracking and UDI, with a clear roadmap to ISO IDMP. Samarind is now part of the Instem Group, the award-winning solution provider.

www.samarindrms.com




Schlafender Hase

Schlafender Hase is the global leader in computer-driven proofreading. Our Text Verification Tool (TVT) is the international benchmark for accurate, user friendly text and graphic verification. TVT is currently used by the world’s leading pharmaceutical and medical device companies as well as numerous regulatory bodies to ensure compliant, error-free packaging.

www.text-verification.com




Sparta Systems

Sparta Systems, an industry pioneer and leading global provider of enterprise software for quality and regulatory management, enables businesses to safely and efficiently deliver their products to market. For more than 20 years, Sparta Systems has been a trusted standard amongst highly regulated industries, used by quality, manufacturing and regulatory affairs professionals to manage regulatory compliance, reduce risk and improve safety across the global enterprise.

www.spartasystems.com




Tarius

Tarius, with over 20 years' experience, supports global regulatory intelligence activities by providing subscription-based access to regulatory information from more than 110 regions, countries and authorities.

Tarius provides a secure place to store, classify and use external and internal documents, in one place. It's a tailored solution matching your individual, regulatory company needs.

www.tarius.com




Veeva

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 500 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.

www.veeva.com




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