Celegence

02/07/2023

We are extremely excited to introduce Waylon Wright, as Business Development Manager, SaaS Solutions at Celegence. Reach out to Waylon if you are considering solutions to better manage your product portfolio and compliance, or simply set-up a demo to learn more about how CAPTIS™ can help.

02/03/2023

📣 It is vital for device manufacturers to maintain a greater level of for their products and ensure access to the market as per Article 61 of the Medical Device Regulation (MDR).

Register for our upcoming webinar/panel discussion on ‘Clinical Evaluation of Dental Medical Devices – Lessons Learned from Notified Body Assessments’ taking place on 📅 28th February 10 AM ET.

🎤 Featuring expert panellists: Dr. Pratibha Mishra, Dr.Alpa Ben, and Anushree Singh, PhD - this exclusive session will discuss the best practices to conduct evaluations of dental and address observations from Notified Bodies, and successfully meeting regulatory requirements.

Follow the link to register: https://lnkd.in/giyAzk6g

Read our full webinar description: https://lnkd.in/ggzJEFcc

Make sure you join us for this webinar about clinical evaluation of dental medical devices & lessons learned from Notified Body assessments.

02/03/2023

Discover how Celegence is supporting several manufacturers of consumable materials, dental equipment, and dental imaging devices and software in high-quality .

Celegence supported the manufacturers for the following activities for their Class I, IIa, and IIb devices:

✅Authoring CEPs, CERs, PMSR/PSURs, SSCPs in accordance with MEDDEV 2.7/1 rev. 4 for compliance to EU/MDR 2017/745
✅Assess adequacy of clinical data based on product history, pre-clinical and clinical studies, complaints, adverse events, and literature
✅Therapeutic Area expert-review of documents
✅Creation of and templates

Click here to read the full case study: https://lnkd.in/gRibjyxC

With a combined total of over 100 years’ experience in the dental devices sector, our team of technical and experts are highly competent and experienced in dental regulatory, documentation, audits and more! Contact info@celegence.com for all your regulatory questions, concerns, and queries.

Celegence provide support to several manufacturers of dental consumable materials, dental equipment and dental imaging devices & software.

02/03/2023

Are you planning to attend DIA this February?

Join Qdossier – a Celegence company's experts in Bethesda between 13-15th February as we take part in multiple speaking sessions including:

🡺 Welcoming Remarks and Presentation of the Excellence in Service Award
Feb 13, 2023, 1:00 PM – 1:25 PM | Ballroom E-H
Michiel Stam, Director of Regulatory Information Management, will join the session for a conversation around Regulatory Informatics.

🡺 Session 7 Track 1: New Developments in RIM Reference Model and IDMP Semantics
Feb 14, 2023, 2:00 PM – 3:15 PM | Ballroom FGH
In this session, Hans van Bruggen, Chief Scientific Officer will present a simpler (object-centric) version of the model.

🡺 Session 8 Track 1: IDMP Ontology: Semantic Interoperability Throughout the Entire Medicinal Product Lifecycle
Feb 14, 2023, 4:15 PM – 5:30 PM | Ballroom FGH
Michiel will provide an outline of the implementation challenges of ISO IDMP standards and showcase how an ontology can help achieve semantic interoperability of product data.

🡺 Session 10 Track 2: Along the Path of Drug Approval; A Hodgepodge of Correspondence With the FDA, EMA Support for SMEs and ICH M11 CeSHarP
Feb 15, 2023, 10:30 AM – 11:45 AM | White Flint (Lower Level)
Michiel and Matthias Sijtstra, Senior Data Management Specialist, will explore insights gained through various FDA correspondence, benefits of EMA’s SME support, and overview the ICH M11 CeSHarP initiative.

And in the days prior to the main event, we will be hosting a ‘𝐕𝐢𝐫𝐭𝐮𝐚𝐥 𝐏𝐫𝐞-𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐒𝐡𝐨𝐫𝐭 𝐂𝐨𝐮𝐫𝐬𝐞: 𝐎𝐧 𝐭𝐡𝐞 𝐑𝐨𝐚𝐝 𝐭𝐨 𝐚𝐧 𝐄𝐔 𝐅𝐢𝐥𝐢𝐧𝐠: 𝐆𝐞𝐭𝐭𝐢𝐧𝐠 𝐅𝐚𝐦𝐢𝐥𝐢𝐚𝐫 𝐰𝐢𝐭𝐡 𝐂𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐄𝐌𝐀 𝐈𝐓 𝐒𝐲𝐬𝐭𝐞𝐦𝐬’ where Matthias will introduce you to the systems that applicants will have to interact with, and which are critical on your road to an EU filing.
Feb 10, 2023, 10:00 AM - 2:00 PM | Virtual.

More info on all of these sessions and the conference can be found in our blog: https://lnkd.in/guva7Fbs

Make sure you join us at the Regulatory Submissions, Information, and Document Management Forum (RSIDMF) from Feb 13-15th in Bethesda.

02/03/2023

Are you looking to navigate complex regulations across your Publishing and Submissions activities?

Staying compliant is time-consuming, so why not take advantage of Celegence’s extensive global regulatory experience and proprietary technology to streamline your Publishing and Submissions management process, including strategic planning, process development, and global alignment.

Download our Publishing & Submission information sheet here: https://lnkd.in/er7-2Nwp

Our highly efficient team of experts can assist you with country specific experience across activities such as:
✅ Dossier submission services to multiple health authorities
✅ Paper to NeeS to conversions in keeping with global health authority formats
✅ Be an extension of your in-house publishing team and the management submission tools with Business Process as a Service ( ) model
✅ End to end services for Publishing, Submission and Archival of for multiple regions
✅ Document Formatting and Publishing – Word Style Guides and PDF Navigation

Celegence provides the highest quality services, with the most efficient time and cost savings in the industry. Learn more about our overall Pharmaceutical Capabilities here: https://lnkd.in/eRAEFd8f

01/31/2023

Is your medical writing team's data extraction process during Systematic Literature Reviews time-consuming and error-prone due to multiple contributors and manual efforts?

CAPTIS™ technology can save your team time and reduce the resources required for Clinical or Performance Evaluations.

Find out how our easily configurable Data Extraction Tables make the entire process of data extraction for your medical devices or diagnostic evaluations substantially more efficient and accurate in our latest feature blog: https://lnkd.in/eKfM3247

Key Benefits of using the customized Data Extraction Tables within the CAPTIS™:
✅ Customized data extraction
✅ Easily set up templates for data extraction to ensure consistency and quality
✅ Data extraction options are always right next to the article when performing literature reviews, allowing you to capture data as you review
✅ Single window approach
✅ Centralized repository to access the entire literature review and associated extracted data

To learn more or to request a personalized demo of CAPTIS™, visit: https://lnkd.in/e__vshzE

Learn about the CAPTIS™ Data Extraction Tables feature which increases speed and accuracy with your systematic literature reviews.

01/31/2023

📣 // Save the date!

Celegence invites you to attend an upcoming webinar and panel discussion titled 'Clinical Evaluation of Dental Medical Devices – Lessons Learned from Notified Body Assessments' on 📅 28th February 10 AM ET.

Led by our services Subject Matter Experts, Dr. Pratibha Mishra, Dr.Alpa Ben, and Anushree Singh, PhD - our expert panellists will discuss practical examples and case studies from Notified Body assessments of Clinical Evaluation Plans and Reports of dental devices prepared for compliance with EU MDR.

Register here for free: https://lnkd.in/giyAzk6g

Find further information on our blog: https://lnkd.in/ggzJEFcc

Make sure you join us for this webinar about clinical evaluation of dental medical devices & lessons learned from Notified Body assessments.

01/23/2023

Celegence is excited to take part in DrugInfoAssn's Regulatory Submissions, Information, and Document Management ( ) Forum, between 13-15th February in Bethesda, MD.

With many of the industry’s leading companies in attendance, we look forward to being able to join a variety of presentations, short courses, and in-person networking opportunities.

Qdossier, a Celegence company will be taking part in various sessions across multiple tracks throughout the event. And are also hosting a Virtual Pre-Conference Short Course titled ‘𝐎𝐧 𝐭𝐡𝐞 𝐑𝐨𝐚𝐝 𝐭𝐨 𝐚𝐧 𝐄𝐔 𝐅𝐢𝐥𝐢𝐧𝐠: 𝐆𝐞𝐭𝐭𝐢𝐧𝐠 𝐅𝐚𝐦𝐢𝐥𝐢𝐚𝐫 𝐰𝐢𝐭𝐡 𝐂𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐄𝐌𝐀 𝐈𝐓 𝐒𝐲𝐬𝐭𝐞𝐦𝐬’ taking place between 10 AM-2 PM on 10th February.

If you are planning to attend the main event in Bethesda, you can visit Celegence’s experts at Booth 102, where we would love to meet you and show you how we support the pharmaceutical industry with the most complex challenges in regulations.

You will also be able to experience demonstrations of Dossplorer™, our cloud-based regulatory dossier management solution for life science companies.

Find out more about our presentations, short courses, and other contributions here: https://lnkd.in/guva7Fbs

01/20/2023

Are you a manufacturer of in-vitro diagnostic medical devices who needs support with technical documentation?

👉 Download your FREE IVDR checklist now https://lnkd.in/e-YQM2ki

This EU IVDR Technical Documentation Checklist aims to assist manufacturers when assembling technical documentation as part of CE marking requirements, as set out in EU IVDR 2017/746.

💡 If you need support in your IVDR journey, we’re here to help! Explore our IVDR services capabilities and offerings: https://lnkd.in/d2UUJDN

Reach out to us at info@celegence.com!

Celegence offers you an EU IVDR checklist to help get your business compliant with the changes to In Vitro Diagnostic Regulations in the EU.

01/19/2023

Check out our latest case study on how Celegence’s team of Evaluation Report (CER) experts successfully assisted a global manufacturer of standalone, cardiac imaging software intended for visualization and post-processing of diagnostic computed tomography and magnetic resonance images with complaint CEP and CER writing in a cost-efficient and timely manner.

The scope of Celegence’s deliverables included:
✔ Software Device 1: Gap Assessment, Addressing Notified Body (NB) observations, CER Remediation
✔ Software Device 2: CEP and CER for initial CE-marking

Click here to read the full case study: https://lnkd.in/gk35BJFP

From consultative services to end-to-end CEP and CER writing capabilities, our expert team can support you in all aspects of your Clinical Evaluation.

Our proprietary technology, CAPTIS™ allows you to streamline and automate all the components of your Clinical Evaluation Plans and Reports. You can learn more about CAPTIS™ solution here: https://lnkd.in/e__vshzE

Get in touch today to discuss your needs by reaching out to info@celegence.com!

Check this case study about how we provided EU MDR compliant CEP and CER services to a cardiovascular imaging software company.

01/16/2023

We are ! We are looking for an experienced Bookkeeper in the Chicago, IL region with 5+ years of experience to join our growing team!

Work alongside our high performing accounting team. You’ll be supporting with financial reports generation, processing invoices, managing customer contracts and optimising our bookkeeping processes.

More details and application form on our website: https://lnkd.in/ddhrSiwz and interested candidates mail in your resume to careers@celegence.com!