Acolad

Acolad Lifesciences has more than 30 years of experience providing life sciences translation and content services with an uncompromising commitment to quality.

We fully understand the challenging universe in which you operate, and that’s why our technology and service solutions are designed to meet industry demands: regulation, validation, and compliance to local and cultural requirements.

Partnering with medical device, pharmaceutical, biotech and clinical research organizations, we provide the highest level of language and content services, unmatched expertise, and industry knowledge that helps save lives.
 
acolad.com

Amplexor Life Sciences

AMPLEXOR Life Sciences is a global provider of regulatory, quality and safety software solutions, serving and trusted by pharmaceutical, biotechnology and medical device companies for over 25 years. Its holistic Life Sciences Suite of solutions helps life sciences organizations to be efficient with launching products and breaking into new markets quickly while ensuring quality, efficacy, and safety through end-to-end support to product lifecycle processes, data, and content management.
 

AmplexorLife Sciences | Global provider of regulatory and quality software solutions

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.
 
www.arisglobal.com

Biomapas

Biomapas is a functional and full outsourcing solution provider to the global life science industry.

As a trusted partner for biopharmaceutical and medical device companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory, pharmacovigilance and medical information excellence across Europe, CIS, EAEU, MENA, LATAM regions and the US throughout the entire product lifecycle. We ensure clients satisfaction by rapid, efficient and cost-effective working practices.
 
biomapas.com

BSI

BSI (British Standards Institution) has over 81,000 clients in 180 countries and is an organization whose standards inspire excellence across the globe. The BSI Medical Devices team has global network of over 4,600 colleagues and over 84,000 clients operating in 195 countries across a range of industries. BSI The Netherlands (2797) is a leading Notified Body; that reviews medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.
 
bsigroup.com

Certara

Roche logo

Certara accelerates medicines using biosimulation software and technology-enabled services to transform traditional drug discovery and development. Our clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.

Certara Insight is the new name of our European regulatory arm following the combination of Insight Medical Writing, AUTHOR!, and Synchrogenix. We assure sponsor regulatory success with our talented medical writers and submissions leaders in the UK, Germany, and the Netherlands.

We are known for our accuracy, consistency and clarity. Our clients rely on our flexible and highly qualified team to deliver mission critical projects on time and budget, enabled by cutting edge Certara regulatory technology.

certara.com

 

DACHS

DACHS has over 25 years of experience supporting life sciences and providing software development services. We offer top-notch software solutions to help regulatory document creation and validation.

OnStyle - Word add-in

  • Document formatting based on strict guidelines
  • Identification and correction of compliance issues

OnTrack - PDF Validation Workspace

  • Automatic document quality checking
  • Identification of 50+ compliance problems

Rely on our powerful tools to produce submission-ready documents of the highest quality.
 
dachs.ch

DLRC

DLRC is an award-winning, leading Regulatory Affairs consultancy employing more than 80 consultants with offices in the EU and United Kingdom. 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 EU, UK, and USA.
 
dlrc.co.uk

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.
 
dwlanguages.com

EXTEDO

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 provide solutions covering the entire regulatory landscape. Today, EXTEDO enables more than 35 regulatory authorities and over 1000 maintained customers across 65 countries to deliver Effortless Compliance™ And our statement why we have decided to take a stand at the Symposium “The TOPRA symposium is a great opportunity for us to meet with our industry and agency customers, partners and other experts from around the world and to exchange information on the latest trends and challenges in regulatory information management.
 
extedo.com

Hobson Prior

Hobson Prior delivers made-to-measure recruitment solutions that empower life science innovators to achieve their potential.
We recognise how building the right team allows your company to thrive and deliver products that make a difference to people’s lives around the world. By taking the time to really understand your exact requirements, we can best represent you in the global market and source contract and permanent life sciences professionals who will contribute to your success.
 
hobsonprior.com

Insuvia

Insuvia is designed to act as a regulatory affairs and pharmacovigilance 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 and pharmacovigilance challenges that pharmaceutical companies encounter while commercializing their products.

 
lnsuvia.com

NDA

NDA is a world-leading regulatory and drug development company, with 25 years of excellence, an extensive portfolio of services, and more than 1600 clients. Over the last three years, NDA Group has supported a quarter of the new medicinal products approved in the US and Europe.

Our dedicated team of over 150 consultants combined with the unique NDA Advisory Board provide drug developers with unmatched regulatory expertise, ensuring the optimal development of complex & innovative treatments that meet the rigorous requirements of the regulatory agencies.

We are a genuine part of our client’s story, and we are a true regulatory partner with one goal in mind, to benefit our client, and ultimately, the patient.
 
ndareg.com

PharmaLex

PharmiwebPharmaLex 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.

pharmalex.com

 

Pharmassist

Pharm Assist is a Nordic consultant and service company offering regulatory solutions for medicinal products and medical devices. A highly qualified team with a strong scientific and regulatory background provides customized services in Regulatory Affairs, Pharmacovigilance, Medical Writing and Quality Assurance to national and international companies.
 
www.pharmassist.se

PharmiWeb.jobs

Pharmiweb 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.

pharmiweb.jobs

 

ProductLife Group

ProductLife Group’s (PLG) mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions.

Since almost 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics.
 
productlifegroup.com

ProPharma Group

ProPharma Group is the global, single-source provider of regulatory and compliance consulting, clinical research services, pharmacovigilance, and medical information serving pharmaceutical, biotechnology, and medical device companies. Founded in 2001, we have 1900 colleagues worldwide. Our solutions help solve complex challenges in a dynamic regulatory environment. ProPharma Group is focused on delivering the highest quality of services throughout the full product lifecycle to improve the health and safety of patients.
 
propharmagroup.com

QbD Group

The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. Since 2011, it has been providing quality solutions for product development and manufacturing. 

The team offers the skills and expertise for solving complex project problems in quality assurance, validation & qualification, regulatory affairs, clinical, quality control, software solutions and go to market for companies active in the biotech, small molecules, digital health, medical device & IVD industries.

QbD Group is headquartered in Belgium and has over 450 consultants worldwide in the Netherlands, Spain, France, UK, Switzerland, Mexico, Colombia and the US.
 
qbdgroup.com

Rapport

DLRC logoRapport is a 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. We have a flex model, providing strategic and tactical support for specific programmes or issues, or we can integrate into your team, building your core capabilities. 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.

rapportss.com

 

SalmITics

DWL logoSalmITics offers IT solutions for the Life Science Industry including software solutions and website development. The Regulatory Cost Optimizer  is a web-based application calculating the total costs of pharmaceutical drug registrations in European countries. Based on up-to-date information on agency fees and manpower rates of each (European) country, it supports pharmaceutical companies calculating their registration costs, including the required manpower, at all stages of their product lifecycle.

salmitics.com

Schlafender Hase

Schlafender Hase provides automated text & graphic proofreading solutions. With its flagship product, TVT®, the Text Verification Tool®, users compare source content with output formats, detecting changes and deviations prior to publication. Schlafender Hase serves regulated industries, the world’s leading pharma & med device companies, as well as healthcare regulatory bodies. TVT reduces proofreading workloads and mitigates the risk of costly errors. Schlafender Hase was founded in 2001.

www.schlafenderhase.com

TransPerfect Life Sciences

TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, pharmacovigilance and safety solutions, translation services, and call center support. With offices in 100+ cities , TransPerfect is the ideal partner to ensure your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement.

lifesciences.transperfect.com

Trilogy Writing & Consulting

At Trilogy, medical writing is our passion. As specialists in regulatory documentation, we provide a service that is more than just writing. Our writers are integral parts of our clients’ teams. We proactively plan, coordinate and write regulatory documents to meet timelines, with a readability that reduces the time for review and approval. Our goal is to help teams streamline their documentation process and make sure their documents communicate clearly and effectively.

trilogywriting.com


TOPRA Symposium 2022
Hilton Vienna Park, Vienna, Austria
Am Stadtpark 1, 1030

Contact us
meetings@topra.org
+44 (0)207 510 2560

#TOPRASym22

Exhibition / Sponsorship
Call +44 (0)2076 510 2573
or email erik@topra.org