2019 TOPRA ANNUAL SYMPOSIUM Logo

2019 Exhibitors

Acorn Regulatory

Acorn Regulatory Acorn Regulatory is a leading consultancy company supporting a global client base. We support companies in their regulatory affairs, pharmacovigilance, clinical trials and quality management activities. Our clients have come to value the benefit of being able to tap into a team of over 50 regulatory and pharmacovigilance professionals. Our team members are all highly qualified and experienced professionals. We have recruited from industry and health authorities to assemble a team that can deliver for your company on every project.

www.acornregulatory.com

Biomapas

Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs and Pharmacovigilance. The company has significant presence across the CEE, Nordic and CIS countries, thereby offering fast and reliable patient recruitment for Phase I-IV and medical device clinical trials, while regulatory and pharmacovigilance services are provided across 4 continents.

www.biomapas.eu

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

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/

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

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

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 850 maintained customers across 60 countries to deliver Effortless Compliance™.

www.extedo.com

Ivowen

IvowenIvowen Limited is a consultancy company based in Ireland who specialise in providing expert advice on Regulatory Affairs and Project Management to the generic pharmaceutical industry. Ivowen Limited provide regulatory affairs support to human and veterinary pharmaceutical companies based in the European Union, EU accession states and worldwide on the successful development and timely registration of their products in the EU and other markets. Ivowen Limited also provide Medical Device, PV, Compliance and Training services.

www.ivowen.com

KLIFO

KLIFO

Maximising opportunity, mitigating risks and driving innovation to achieve efficient project advancement. KLIFO is an integrated drug development consultancy with significant experience in partnering with biotech and pharma to advance their drug development projects. From our offices in Denmark and Germany we offer expert consulting and operational services throughout the drug development process. KLIFO Regulatory Affairs Solutions merges competence and experience to provide sound advice and to assist in navigating all regulatory requirements.

www.klifo.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

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/

PharmaLex

Pharmalex PharmaLex supports pharma companies throughout the entire product lifecycle, ensuring compliance with pharmaceutical regulations and providing vital scientific and strategic advice on drug development. Our services extend beyond market approval and include product maintenance post launch activities. PharmaLex differs from other providers by focusing on specialised regulatory services (rather than clinical ops, manufacturing or sales support) to deliver and comply with all health agency obligations. Our global team has more than 850 local knowledge experts.

www.pharamlex.com

 

Pharm Assist

Pharm Assist is a consultant and service company offering regulatory solutions for pharmaceuticals and medical devices 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

 

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
  

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

Real Regulatory

Real Regulatory Real Regulatory has vast experience with medicinal product development and clinical trials in Europe. We advise our clients on development plans and clinical trial strategy, assess FDA packages for EU suitability, lead Scientific Advice meetings, and build normative documentation for submissions, including MAA, orphan designation and PIPs. We actively provide hands on support of Clinical Trial submissions throughout Europe for both Competent Authority and Ethics Committee approvals.

www.realregulatory.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

Regulis

RegulisRegulis is a regulatory affairs, pharmacovigilance and quality compliance consultancy, specialising in delivering client growth and protecting client assets. From the strategic to the operational, we get you through the maze of regulation for medicines, biotechnology products, medical devices and borderline substances. We work with companies to speed their products to market and protect their patients and the value of their products.  With our knowledge and expertise, Regulis increases revenue, decreases risk and reduces cost for clients globally.

www.regulis.com

Schlafender Hase

Schlafender Hase Schlafender Hase is a leader in intelligent, automated proofreading solutions for the global life sciences industry. Committed to product innovation, service excellence and customer success, Schlafender Hase’s client roster includes all of the top 15 global pharmaceutical companies and more than half of the global medical device companies. These organisations rely on Schlafender Hase’s text and graphic verification platform to ensure compliant, error-free and consistent packaging. Founded in 2001 the company is headquartered in Frankfurt, Germany and has a North American office in Cambridge, Massachusetts.

www.schlafenderhase.com

Syneos Health

SyneosHealth Syneos Health is the only fully integrated biopharmaceutical solutions organization. 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. To learn more about how we are shortening the distance from lab to life™ visit SyneosHealth.com.  

www.syneoshealth.com

TransPerfect Life Sciences

TransPerfect Life Sciences logoTransPerfect Life Sciences specialises in supporting global development and commercialisation of drugs, treatments and devices designed to improve and save lives. Our comprehensive solutions include eTMF and e-clinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call centre support. With offices in over 90 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact.

www.transperfect.com

Veeva

Veeva logo 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 700 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay area, with offices throughout North America, Europe, Asia and Latin America. For more information, visit www.veeva.com.

www.veeva.com
 

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/