Improving health outcomes through regulatory excellence


2024 Exhibitors

3D Communications

For more than 20 years, 3D Communications has prepared pharmaceutical, biotech, and medical device companies for high-stakes interactions with US and EU regulatory authorities - helping them build the skills they need to communicate effectively.

3D’s science, regulatory, communications, and market access experts leverage their proven 3D ACT® process and state-of-the-art technology to help clients transform complex information into clear and convincing messages and presentations—and deliver with confidence and purpose.

  



Arex Advisor

Arex offers a full suite of regulatory expertise, at your fingertips. Their mission is to help leaders and companies in pharma and biotech realise projects and reach goals. They complete your global regulatory affairs team, securing development, as well as implementation, of your regulatory strategy. Your dedicated contact person comes with a selection of experts to support your success - from development to commercialisation.

Arex's experts lead the way with proven methods for efficiency and compliance. They manage risks and identify opportunities throughout your journey. Being agile and adaptive is part of their philosophy. When you need Arez, they are easy to reach, ready to give advice and act. Arex tailors solutions to support your success. 



ArisGlobal

ArisGlobal is transforming the way today’s most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance,
delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China.
  



Arriello

Arriello is a leading consultancy and solutions provider of risk management and compliance services to the pharmaceutical industry. They have been making the development-to-market process faster, better, and smarter since 2008.

Their global services span the product life cycle from Clinical to post-submission Regulatory Affairs and Pharmacovigilance, Quality Assurance and Auditing, and innovative automation solutions. Valued clients rely on their ability to deliver, however complex their requirements, through their proven expertise, global coverage, and technology. 
 



Billev Pharma East

Committed to ensuring your products and GxP systems meet compliance standards, Billev Pharma East is dedicated to staying ahead of regulatory changes with actively contributing to the development of new legislation through international organizations, ensuring we offer the most current consultancy services. Since our establishment in 2007, our growth has been fuelled by the loyalty of our customers. This support has enabled us to continuously provide up-to-date consultancy, making us a trusted partner in navigating the complex regulatory environment. 
 



Biomapas

Biomapas is a premier contract research organization (CRO) delivering flexible solutions globally throughout development as a seamless extension of your team. Our colleagues spread through all European, Commonwealth of Independent States (CIS), Eurasian Economic Union (EAEU) and Middle East/North Africa (MENA) regions can enhance your drug development, accelerate your path to market authorization, and ensure compliance with local and global post-marketing requirements. we do so through a complete service scope in clinical research, regulatory affairs, pharmacovigilance, and medical information. .

 

 



BSI

BSI understand the challenges manufacturers face in bringing compliant products to market efficiently with absolute safety for patients. As a leading full scope EU Notified Body and UK Approved Body, they strive to set the global standard through conducting impartial, responsive, robust, and thorough conformity assessments, evaluations and certifications that are recognized and trusted worldwide.
 



Canopy Life Sciences

Canopy Life Sciences provides clinical to commercial solutions to over 225 biotechnology, pharmaceutical, and medical device companies. The company offers consulting and operational support services in the areas of Regulatory Affairs, Regulatory Operations (eCTD, CTIS/CTR), Medical Affairs, MLR, Content Innovation, Veeva Support Services, and Global Recruiting.
 



Cencora PharmaLex

PharmaLex is now part of Cencora, a leading global pharmaceutical solutions organization centered on improving lives around the world. 

PharmaLex adds to Cencora’s expanding suite of pharma solutions and serves the pharma, biotech, and medtech industries. We guide clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology-elevated solutions to support clients through the entire product lifecycle.

 


 



Cpl Life Sciences

Cpl Life Sciences works exclusively within the regulatory functions of the Pharmaceutical, Biotechnology, Medical Device, and Diagnostics industries across the US, Europe, and the UK.

Our regulatory affairs team supports life science organisations by offering Total Talent Solutions. We provide our partners with a strategic and consultative approach to meet each client's needs, whether it involves working with a single regulatory consultant, delivering a specialist project or outsourcing an entire functional regulatory team.

 

 



Datapharm

Datapharm provides accurate, up-to-date medicines information to patients and healthcare professionals throughout the UK while supporting Pharma with their digital processes. It runs emc (electronic medicines compendium), the UK’s most comprehensive, trusted and accessible source of information on medicines, listing nearly 10,000 medicines and attracting a growing audience of over 85 million visitors per year. It is a Pharma-preferred partner, providing innovative software solutions to support these companies' regulatory, compliance, market access and market intelligence functions, and serving more than 320 Pharma customers in the UK.
 



DLRC

DLRC is an award-winning, leading regulatory affairs consultancy employing more than 80 consultants with offices in the UK and Germany. Our experienced team provides comprehensive strategic and operational support to the pharmaceutical, biotechnology, medical technology, and related industries. DLRC specialises in supporting the development, approval, and commercialisation of healthcare products across the major markets including the EU, UK and USA.
 



DWL

DWL is the Life Sciences division of the fastest growing Language Service Provider (LSP) in the world – BIG Language Solutions. With 60 years of experience, DWL provides language solutions to leading Life Sciences organisations in the pharmaceuticals and medical devices sectors as well as academia and clinical research. Our specialist global supply chains are underpinned by in-house medical expertise. DWL supports your business goals through language services which are unified, effective and secure.
 



ELIQUENT Life Sciences

ELIQUENT Life Sciences is built on the foundation of five legacy global life science consultancies. RApport Global is now working together as an aligned, coordinated regulatory team. ELIQUENT delivers comprehensive solutions that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape. This unprecedented assembly of regulatory experts enables a unique understanding of the life sciences industry, and the unmatched expertise companies need when navigating today’s evolving regulatory environment.



ESPL Regulatory Consulting

ESPL is the only regulatory consultancy in the UK owned by its team of friendly, can-do regulatory professionals, with an extensive range of experience and enthusiasm for medicines, biologics, medical devices, and borderlines. Over the last 24 years, the team has supported clients with all types of submissions, at all stages of development and lifecycle: from early strategic support, orphan designations (EU and US), through clinical development to MA submissions and maintenance activities including publishing, STED preparations, and liaising with regulatory agencies worldwide. We also provide bespoke training in-house for QP's and TOPRA.
 



EXTEDO

EXTEDO is a leading provider of Regulatory Information Management solutions, optimizing eRegulatory processes across content, quality, product registration, submission, and safety management. Today, EXTEDO serves over 1,000 clients and 35 regulatory authorities globally.

Asphalion, a regulatory consultancy, collaborates with Pharmaceutical and Biotech companies to facilitate Drug Development and Regulatory Affairs & Safety projects. Their involvement ranges from early development through registration and post-commercialization phases.

We deliver end-to-end life sciences solutions and services, accelerating market entry and enhancing patient safety worldwide.

 


 



Fera Science

Fera Science is participating in the TOPRA Symposium to forge new connections in the human health and veterinary medicine sectors. With a track record of supporting clients in environmental risk assessments, Fera collaborates closely to diminish risk quotients and refine PEC values, contributing to the successful registration of novel products. The TOPRA Symposium presents a valuable platform for Fera to stay informed, engage with industry professionals, and further strengthen its commitment to effective environmental risk management.
 



Fortrea

Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry based in 90 countries, leveraging three decades of experience through multiple therapeutic areas. We partner with emerging and large biopharmaceutical, medical device, diagnostic companies to drive healthcare innovation that accelerates life-changing therapies to patients. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, regulatory strategy consultancy, differentiated technology-enabled trial solutions, and market access services.
 



Generis

Generis is a UK-headquartered developer of world-class data, content and business process management for regulated industries globally. 60% of the top 20 life sciences companies rely on Generis’ flagship CARA™ Life Sciences Platform, including AbbVie, UCB, Biogen, Reckitt, Bristol Myers Squibb, Bayer, Pfizer, and Merck KGaA. Today Generis serves more than 750,000 users worldwide, across use cases ranging from RIM, Regulatory / R&D and Safety use cases to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information / Medical Affairs applications and more. 



Ideagen PleaseReview

Ideagen PleaseReview revolutionises the process of creating, reviewing and redacting crucial regulatory filings, spanning from INDs and NDAs to protocols, CSRs, MAAs and beyond. Our intuitive web-based platform facilitates seamless collaboration, allowing internal and external teams of any scale to work together securely and efficiently. With a single click, you can generate comprehensive activity reports for unparalleled audit preparedness. Trusted by 85% of the top 25 global pharmaceutical companies, Ideagen PleaseReview accelerates timelines, enabling faster drug market entry. 
 



Insuvia

Insuvia is designed to act as a regulatory affairs unit for pharmaceutical companies in those countries and regions, where they have no internal structures or decide to focus their resources on commercial activities. In this context, we provide the regional EU and country-level expertise to solve all regulatory affairs challenges that pharmaceutical companies encounter while commercializing their products.
 



Kinesys Consulting Ltd.

Kinesys Consulting Ltd. provides strategic advice and support in regulatory affairs, medical / regulatory writing, and medical devices to drive your products through development, registration, and market launch. In doing so, our aim is to set and maintain the highest regulatory standards for both investigational and marketed products. We treat your products and projects as if they were our own. Your end-to-end partner for support throughout the development programme and beyond



Linguamatics

When it comes to global markets, regulatory submission is one of the most sensitive areas of the product life-cycle. Because we know it from our healthcare and clinical background, we have created a global regulatory submission solution our customers can truly rely on. Local regulatory expertise you can trust, full project management capabilities and a wealth of linguistic expertise make Linguamatics the partner of choice for your multilingual initiatives.
 



MAIN5

MAIN5 redefine consulting with a dynamic and forward-thinking approach: they stand for unparalleled expertise, tailor-made solutions and partnership-based collaboration. With over 60 dedicated professionals, they are committed to driving innovation and digital transformation for our clients. 

Our consultants form a dynamic assembly of seasoned professionals, comprising regulatory industry experts, digital transformation specialists, and operational efficiency mavens. Spanning the entire spectrum of the Life Sciences Industry, from pharmaceuticals and biotechnology to medical devices and healthcare technology, our collective expertise is unparalleled.

 

 



NSF

NSF provides a comprehensive range of support services for the pharmaceutical, medical device/IVD, and nutritional supplements industries covering consulting, training, and auditing on a global basis.

Their team of ex-regulators and renowned industry experts work with companies around the world on Global Regulatory Affairs; GMP Readiness Audits & Mock Inspections; QMS & Compliance Support; Enforcement Support & Remediation; and Training & Education Solutions.
 



PharmiWeb.jobs

PharmiWeb.jobs is the world’s largest Life Science Job board. With over 5,000 live jobs from the key players in the Life Science industry, PharmiWeb.jobs is the best place to find or advertise your next role. Search PharmiWeb.jobs now or upload your CV and let the jobs find you! Our clients benefit from a CV Database, Employer branding training and market insights. Contact us today and see what PharmiWeb can do for your business.

 

 



ProPharma

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s leading regulatory consultancy, ProPharma’s Regulatory Sciences team partners with its clients at any point throughout the product lifecycle, helping them achieve regulatory success. Our team of experts take an unparallelled approach, combining extensive scientific knowledge with deep regulatory expertise that de-risk the regulatory process and accelerate regulatory approval of our partners’ most high-profile drug and device programs.
 



Schlafender Hase

Schlafender Hase delivers an easy-to-use document comparison software for regulatory affairs to reduce the time you spend proofreading. Our solution, TVT®, catches even the smallest differences, ensuring that only approved content is printed or published. Easily verify text, artwork, barcodes and spelling.

Designed for and proven within the highly regulated life science industry, TVT is currently used by 20 of the top 20 life science companies and standardized globally by 13 of the top 20.



Transperfect Life Sciences

TransPerfect 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 eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. 
 



Venn Life Sciences

Venn Life Sciences is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials, providing end-to-end early clinical development services for our broad and longstanding global client base of biopharma companies.
 



Veristat

Veristat is a scientific-minded global clinical research organization (CRO) and consultancy that integrates full service clinical trial execution, regulatory consulting, and strategic planning to rapidly advance the development, approval, and commercialization of revolutionary therapies around the globe.
 



Vivpro

Discover the future of biotech and pharmaceutical decision-making with Vivpro. Our cutting-edge bio-intelligence software platform empowers industry leaders with lightning-speed insights for evidence-based clinical, regulatory, and business strategies. Revolutionizing how pharmaceutical, biotech, and medical product companies operate, we fuse technology with expertise to navigate complex challenges effortlessly. With our R&D Intelligence Assistant (RIA), craft-winning product strategies with faster decisions, superior strategy and better quality! ;



Poster Competition sponsor: RegFile

RegFile is a regulatory affairs consultancy. We write and publish marketing authorisation eCTD dossiers and run marketing authorisation applications / new drug applications. We handle post-authorisation regulatory affairs, with focus on the Nordic region. RegFile is headquartered in Uppsala, Sweden and is part of the Center for Translational Research (CTR) group, together with our sister companies RegSmart, Clinical Trial Consultants, Toxicology Knowledge Team, Lablytica, MetaSafe, QAlliance and Zelmic.”
 

Coffee Break sponsor: Base Life Science

BASE life science is an innovative and forward-thinking technology, product and service consultancy specialized in creating business value from digital platforms and data. Our experienced teams optimize technology and business processes within the life sciences industry.

Powered by our dedicated teams’ hard work and efforts, BASE life science has been cemented as a reliable advisor in the life sciences industry, striving for continuous excellence to remain an entrusted partner that can bring our customers visions successfully to life.
 

Delegate Bags sponsor: Linkfield Life Sciences Ltd

Linkfield Life Sciences Ltd is a specialist Regulatory Affairs Recruitment Partner, dedicated to the Life Sciences sector. With 12 years of experience, we excel in filling roles across the entire product lifecycle. Our deep understanding of regulatory requirements enables us to attract top candidates and deliver targeted recruitment solutions. We cover roles in Senior Leadership, CMC, Clinical/Pre-approval, Lifecycle Management, Post Marketing, Operations, Strategy, Writing, and Medical Devices, serving clients across the US, Europe, and the UK

TOPRA Symposium 2024
Postillion Hotel & Convention Centre WTC Rotterdam,
Beursplein 37, Meent 110,
3011 AA Rotterdam, Netherlands

Contact us
meetings@topra.org
+44 (0)20 7510 2560

#TOPRASym24

Exhibition / Sponsorship
Call +44 (0)20 7510 2573
or email erik@topra.org