- Consultancy
Strategy and procedures
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Document and submission management
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Dossplorer regulatory dossier viewer
Submission document templates and content plan
- Customers & Cases
April 2020
Meet us at LorenzLink
LORENZlink is our industry-wide RIM forum in North America with a philosophy to Converge, Connect and Collaborate. The event brings LORENZ customers, partners and others interested in Regulatory Information Management together to network, share practical experiences and best practice know how on a wide range of topics impacting Regulatory Affairs Professionals. More information on the event can be found here.
Find out more »May 2020
Meet us at Amplexor’s Virtual Be The Expert 2020
BE THE EXPERT 2020 brings together leading subject matter experts and industry professionals from around the world into one forum to discuss and exchange strategies that combat the challenges in an ever-changing regulatory landscape. You will walk away with enhanced knowledge that will position you to achieve positive results and transform the processes and technology within your business environment. For the first time in 22 years, we are excited to announce that our annual BE THE EXPERT 2020 conference will be…
Find out more »June 2020
Meet us at Virtual DIA Europe
DIA EUROPE 2020 GOES VIRTUAL! We're pleased to announce that much of the invaluable content, communication and community that defines DIA Europe will still go on, in the digital realm. The lively panel presentations, insightful Q&A sessions, and deep community exchanges you've come to expect will be carried on, through DIA's digital technology. DIA Europe is a must-attend event for life science professionals from across the entire drug development spectrum - from discovery to marketed use – to facilitate open…
Find out more »September 2020
Meet us at Lorenz UserBridge
This annual conference attracts LORENZ customers, partners and other regulatory professionals for two and a half days of presentations, networking and exchange of ideas. Learn, discuss and interact with industry and agency professionals! More information on the event can be found here.
Find out more »February 2021
RSIDM 2021: Qdossier presenting on IDMP & Data Management
DIA’s Regulatory Submissions, Information, and Document Management Forum (RSIDM 2021) brings together industry and regulatory stakeholders working across the scope of regulatory information to examine current data standards and requirements and effective regulatory information management approaches to align related systems. The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates…
Find out more »March 2021
Qdossier-Generis webinar: a pre-configured and validated hosted platform for data governance, document authoring, dossier compilation and dossier viewing
REGISTER NOW (FOR FREE) This webinar is co-organized by Generis and Qdossier. The speakers will illustrate how the hosted platform offers a one-stop-shop for all you need in relation to (regulatory) data, document and dossier management. The platform will comprise Generis's CARA Life Science Platform(TM), a content management platform, configured and validated according to Qdossier's Best Practice; Qdossier's Dossplorer(TM) dossier/eCTD voewer amd Dosscriber(TM) eCTD templates; and an eCTD builder solution; along with Qdossier's services for user administration and change control…
Find out more »April 2021
Filing eCTD Submissions Training Course – Management Forum
On April 13th, Maikel Bouman and Marloes van der Geer present a 1-day eCTD submission training course, which is part of the Management Forum training curriculum. During that training, they will give a general eCTD introduction and share the Qdossier best practices in relation to eCTD preparation, submission and lifecycle-management. This training will give participants not only the right level of knowledge to get started with eCTD submissions. In addition, it directly provides attendees with right practical advice on how…
Find out more »September 2021
QDossier Presenting on FDA Drug Approval Process
During this course, you will gain a deep understanding of the eCTD submission process for FDA drug approval. This program covers procedures for submission of INDs, NDAs, ANDAs, and 505(b)(2). It provides a useful insight into the organization and structure of the FDA and its review processes and highlights recent changes. The course is well structured and organized in 8 modules which helps the audience to understand the entire drug approval process in a continuous flow. Module 1: History and…
Find out more »October 2021
QDossier Presenting on Filing eCTD Submissions
Join us for this intensive one-day training course on filing eCTD submissions. This course will provide in-depth knowledge on components of eCTD and how to build a dossier right the first time using MS word templates. By getting insights from trainers who have vast experience in eCTD submissions, you will learn how to build, publish and deliver successful submissions across the EU and the US. An interactive case study session will provide practical knowledge and explore the challenges during eCTD…
Find out more »QDossier Presenting on Registration and Impact of SmPC on Market Access
Regulatory approval does not ensure market access to a drug. Purchasing policy, reimbursement applications, and clinicians’ prescribing decisions are equally important to ensure drug accessibility to the patients. Marloes will present the first module of the NEW Smelt Academy market access program. In that module, she will focus on the EU registration process of human medicines. Thereby she will do a deep dive into the development process of an SmPC and discuss the important role that SmPC-wording has down the…
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