Improving health outcomes through regulatory excellence


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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.

  



Arazy Group

Arazy Group are a leading consulting firm specializing in regulatory affairs and product registration for medical devices and IVD products. Their mission is to make the best medical devices and medical practice available to patients and physicians worldwide. With over 25 years of experience, their team has helped thousands of MedTech companies successfully navigate the complex registration processes, providing tailored solutions that meet each client’s unique needs. Arazy Group work closely with their clients to understand their specific requirements and provide effective and efficient solutions that enable them to gain and maintain market access in multiple countries throughout the product life cycle.



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.
 



Cencora PharmaLex

Cencora PharmaLex is part of Cencora, a leading global healthcare company centered on improving lives. Together, we offer end-to-end product commercialization, including global market access strategy and execution, to drive patients’ healthier futures wherever they are in the world.

We service the pharma, biotech and medtech industries, guiding 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.

 



Datapharm

As the providers of emc (medicines.org.uk), we are looking forward to connecting with the Regulatory Affairs community at this year's TOPRA Symposium, to network and gain valuable insights. Given the expected code updates for pharma, we view this symposium as an ideal platform to discuss its impact as well as regulatory challenges and opportunities. - Eliot Morton, Sales Director, Datapharm.
 



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.
 



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 solutions and services provider in the field of regulatory information management (RIM). Together with trusted partners such as ASPHALION, we focus on optimising our clients' eRegulatory business processes and provide solutions covering the entire regulatory landscape. Today, EXTEDO enables more than 35 regulatory authorities and over 1,000 maintained customers across 65 countries to deliver effortless compliance.

 



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.
 



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



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.

 

 



RApport

DLRC logo

RApport is a UK-based international regulatory and product development consultancy with a team of highly experienced experts, including ex-Regulators from across the globe to provide innovative solutions to global programmes. RApport has a proven track record on delivering successful drug/device development, including designing CMC, non-clinical and clinical programmes, preparing robust risk registers and mitigation plans including a Strategic Advisory Panel service (AdvizON), all of which has helped inform clients to identify accelerated pathways to drug/ device approval.



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 are problem-solvers, scientific experts and regulatory upholders. They engage with clients collaboratively to support their delivery of life-changing therapies and are equipped to take the lead on any development and commercialization program. With their focus on novel drug development and 30 years of experience in clinical trial planning and execution, they deliver bold approaches that make the impossible possible..
 



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! ;




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