Gold Exhibitors

Amplexor

Amplexor logo AMPLEXOR Life Sciences helps pharmaceutical, medical device and biotechnology organizations launch products and break new markets quickly. Our solutions and services expedite the creation and delivery of consistent, compliant and high-quality global content – both physical and digital – across all target countries. Its services include technology consultancy, implementation and management services, as well as technical writing, medical translation and linguistic validation services.

www.amplexor.com

Blue-Reg

BlueReg Pharma Consulting logo Blue-Reg is a consultancy company specialised in Regulatory Affairs, Drug Development and Pharmacovigilance. Our services can be tailored to meet your needs in terms of consultancy, writing, preparation, publishing and submission of Regulatory dossiers. Our flexible approach and dynamic team, with extensive hands-on industry experience, will guide you to project success.

www.blue-reg.com

Cardinal Health Regulatory Services

Cardinal Health logo As your global product development consultants, Cardinal Health Regulatory Sciences will work closely with you throughout your approval journey – from early clinical testing to post-approval maintenance. Our dedicated client service teams help to ensure projects stay on track, and on time. Let us put our proven regulatory consulting to work for you.

  • 200+ regulatory and scientific experts average 18 years of industry experience
  • Our clients have achieved more than 100 approvals
  • We’ve worked with nearly 1,000 companies worldwide
www.cardinalhealth.com 

DLRC

DLRC logo DLRC Limited is a leading Regulatory Affairs consultancy boasting more than 450 years cumulative experience. Our dynamic and award-winning team provides a comprehensive regulatory affairs service from strategic advice in early drug development, to compilation and management of regulatory submissions.  Since 2005 DLRC has helped companies of all sizes to maximise the commercial value and timely marketing of their products. We are also proud holders of the Queen’s Award for Enterprise in International Trade.

www.dlrc.co.uk/

DWL – Dora Wirth Languages

DWL 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

i-Pharm

i-Pharm logo We are an award-winning international life sciences recruitment company with offices in London, New York, Munich, Singapore and Sydney.  In a highly competitive marketplace, we connect top talent with the very best opportunities across the major global life science hubs. The i-Pharm Regulatory Affairs practice was founded in 2008 and our clients include many of the most successful and innovative Pharmaceutical, Biotechnology, and Medical Devices companies, as well as a range of CROs and specialist Regulatory Affairs consultancies.

www.i-pharmconsulting.com/

 

Kinesys Consulting

Kinesys provides Regulatory Strategy, Writing and Submissions services. This extends to all types of Regulatory Applications – MAA, Scientific Advice, CTA/IND, Orphans, PIPs / iPSP and Expedited Pathways (PRIME, Breakthrough, PIM, etc). We are experts in several areas including Haemato-Oncology, Immunology, Inflammation and Orphan Drugs generally, while our experience includes NCEs, biotech agents, devices and cell therapies. We work with large Pharma and Biotech companies as well as start-up firms.

www.kinesysconsulting.com/

NAMSA

NAMSA is a Medical Research Organisation (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialisation to post-market requirements, anywhere in the world.

www.namsa.com/

NDA

NDA logoNDA is a world-leading drug development consultancy with a dedicated team of over 150 consultants supported by an expert network and a specialist Advisory Board. Our experts are leaders in clinical and regulatory drug development, payer strategy and high-stakes meeting preparation. We streamline the global process to accelerate patient access to important medical therapies. NDA supported over 40% of the new medicinal products approved in the EU over the last five years.

www.ndareg.com/

ProductLife Group

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

QualiMetriX

QualiMetriX is a third-party contract laboratory that provides a wide range of integrated services to the pharmaceutical industry. Services include Pharmaceutical Products and Medical Devices; with full support given to the regulatory requirements and research challenges.

R&D and QC activities include but are not limited to: analytical development and validation; leachables and extractables; elemental impurities; stability studies; batch release; filter validation; identification of unknown impurities; skin permeation studies for locally applied products; biological risk assessment; chemical characterisation; cytotoxicity; irritation; sensitisation tests.  
 
www.qualimetrix.gr

SDL (formerly Donnelley Language Solutions)

SDL SDL, formerly Donnelley Language Solutions, is the global leader in content creation, translation and delivery. For over 25 years we’ve helped life sciences organizations communicate with confidence and deliver transformative business results by enabling powerful experiences that engage customers across multiple touchpoints worldwide. 

www.SDL.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 600 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/eu
 

Voisin Consulting Life Sciences (VCLS)

VCLS logo Voisin Consulting Life Sciences (VCLS) specialises in consulting to innovative life science: biotechnology medtech and pharmaceutical companies. VCLS supports its clients throughout product development from the design of global development plans and regulatory strategies, to their implementation and submissions to regulatory agencies and payers. Its expertise encompasses the full spectrum of HealthTech products: drugs, biologics, cell and tissue therapies, medical devices including digital, in-vitro Diagnostics/CDx, combination products, as well as nutraceuticals and cosmeceuticals. Our services mainly cover Regulatory Affairs, Market Access, Clinical Research and Safety & Pharmaco-Vigilance.

www.voisinconsulting.com/

 
Silver Exhibitors

Biomapas

Biomapas

Biomapas – a Full Service CRO. We are a team of professionals experienced in Clinical Trials, Regulatory Affairs, Medical Writing and Pharmacovigilance services. For more than 17 years Biomapas has supported Pharmaceutical, Biotech and Medtech companies with client-based solutions in Europe, Russia, CIS and the Americas. We are an ISO 9001 and 13485 certified company since 2012.
 
www.biomapas.eu

Cambridge Design Partnership

Cambridige Design Partnership logo Cambridge Design Partnership is a technology and product design partner focused on helping clients grow their businesses. Our experts in engineering, quality assurance, regulation, and human factors offer a unique end-to-end service: from initial design and development, to manufacturing and beyond. Specialists in medical device development, certified to ISO 13485, we can ensure your next product is patient-focused and commercially effective.

www.cambridge-design.co.uk/

Diamond Pharma Services

Diamond Pharma Services is a leading technical and scientific consulting group with an emphasis on the following areas:

  • Regulatory Affairs: Product Concept to Registration and Beyond
  • Product Development: Nonclinical, CMC and Clinical Aspects
  • Pharmacovigilance: Clinical trials, Post-Marketing and QPPV Services
  • Compliance: GxP and QP Services
www.diamondpharmaservices.com/

DocShifter

Docshifer logo DocShifter provides compliant content transformation solutions for all your regulatory and other corporate content. Our solutions are used by life sciences organisations of all sizes to drastically speed up and simplify their rendering and submission processes while also significantly reducing any associated costs. When was the last time you reviewed your rendering platforms? Think differently; think DocShifter. 

www.docshifter.com

DRA Consulting Oy

DRA Consulting logoDRA Consulting Oy is a Finnish privately-owned consultancy company and a trusted partner of more than 250 pharmaceutical companies in Europe. We are a forerunner in regulatory expertise, medical affairs and market access with a thorough understanding of the entire lifecycle of medicinal products and the Nordic pharmaceutical market. 

www.dra.fi

EXTEDO

Extedo Regulatory Affairs EXTEDO is a leading software solutions and services provider in the field of eCTD and Regulatory Information Management (RIM). We focus on optimising 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

Gilead Sciences

Gilead Sciences logo Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. 

www.gilead.com

Hobson Prior

Hobson Prior logo Hobson Prior is a leading specialist life sciences recruiter, focused on finding outstanding candidates across Europe, USA and Asia Pacific. We work proactively with our clients and candidates and invest time to understand what you are looking for so we can expertly match you with the best opportunities.

www.hobsonprior.com

Medfiles

Medfiles is a leading Nordic and Baltic CRO offering a one-stop-shop service across Europe. With extensive expertise in human and veterinary medicinal products, medical devices as well as food and food supplements, we can help you achieve your goals faster and more efficiently. Medfiles – securing a healthier tomorrow.

www.medfiles.eu

Pharm Assist

Pharm Assist is a consultant and service company offering regulatory solutions for pharmaceuticals and med-tech products since 1996. A highly qualified team with a strong scientific and regulatory background provides customised services in Regulatory Affairs, Pharmacovigilance, Medical Writing and Quality Assurance to national and international companies.

www.pharmassist.se

PharmaLex

PharmaLex logo PharmaLex is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology & Risk Management worldwide. Our global teams of experts can take you through early strategic planning activities, through regulatory submission processes and guide you to market approval and product maintenance activities.

www.pharamlex.com

ProClinical

ProClinical Logo 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
  

Regulatory Professionals

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

www.regulatoryprofessionals.com

Schlafender Hase

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/

Syneos Health

Syneos Health is the only fully integrated biopharmaceutical solutions organisation. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.  

www.syneoshealth.com