Regulatory Writing

“Working with Celegence on our publishing and submission activities has delivered significant value. Their client-focused approach, combined with deep regulatory knowledge and smart tools like Dossplorer, enabled real-time collaboration and faster decision-making. Thanks to their support, we were able to meet tight deadlines without compromising quality—cutting publishing time significantly for major submissions and reducing rework substantially. Celegence’s professionalism, responsiveness, and commitment to our success have made them an essential extension of our internal team. We’re confident that with Celegence, we have the right partner to support our regulatory operations moving forward.

“We are very satisfied with our collaboration with Celegence. For several years now, we have been relying on them for the XEVMPD submission of our data. On the strength of this positive experience, we have extended their scope of intervention to include data entry in LifeSphere and are now embarking on a new project to enrich our IDMP data in this same solution. Their in-depth expertise and perfect understanding of regulatory requirements, combined with a pragmatic, results-oriented approach, have significantly enhanced the quality and efficiency of our data management processes. What sets Celegence apart is their ability to quickly identify our specific needs and propose tailor-made solutions, which is a key factor in our success. Their structured and proactive support enables us to reach important milestones with serenity and clarity. As we continue to transform our regulatory operations, choosing Celegence as our long-term partner was a natural strategic decision. We look forward to continuing this fruitful collaboration.

“I have been working with Celegence for several years and very much appreciate their partnership on so many levels. Celegence has very strong CMC experience and not only provided us much needed consultant services, but they also worked with us to utilize and leverage industry-disrupting digital solutions, Dossplorer™ and CAPTIS®. These tools have changed how we access and use our own data. Dossplorer™ (a dossier viewing tool) was upgraded with industry leading features such as translation, a goggle-like power search, document compare and many others that drastically reduce the time it takes to perform change impact assessments, document comparisons, translation and search within non-English documents and the ability to upload many other critical Health Authority documents keeping our dossiers fully compliant and current. Since Dossplorer could be used by anyone in Kenvue, it gave this power to all our stakeholders and business partners as well. CAPTIS® (an AI enabled technical/medical writing tool) was piloted with the CMC team in Kenvue to see where we could leverage using AI to author Module 3 quality submission ready documents. The Celegence team was able to automate technical writing for 5+ of the most frequently written Module 3 quality submission documents to streamline our life cycle management workload and resources. The documents Celegence provided using their AI tool were shown to be remarkably reliable when compared to manual preparation. This pilot showed the art of possible. We achieved great things with Celegence and appreciate their collaboration and expertise.

“Partnering with Celegence for our publishing and submissions has been a game-changer. Their combination of knowledgeable, client-focused experts and technology-enabled services has dramatically improved our efficiency. The use of Dossplorer’s real-time review and commenting capabilities played a pivotal role in meeting tight submission deadlines. From collaborative document preparation to seamless eCTD publishing, their tools and expertise have directly accelerated our submission and approval timelines. With Celegence’s support, we cut our publishing time in half, minimized rework, and consistently met aggressive timelines. Their responsiveness and commitment to excellence make them one of our most reliable business partners. I would never hesitate to recommend their services."

“Celegence has consistently demonstrated the value of their tech-enabled services in improving efficiency and compliance. The use of eCTD templates saves significant hours of document readiness and rework – streamlining the preparation and reducing publishing timelines. These templates consistently deliver hard returns on investment, helping organizations save time and resources. Additionally, the use of Dossplorer’s real-time review and comments feature was instrumental in meeting submission timelines, which otherwise might not have been achievable. From document collaboration to seamless publishing, Celegence’s tools and expertise are driving measurable time-to-market improvements and enabling success where it matters most. Celegence’s tech-enabled services consistently deliver immediate value. Qdossier supported by eCTD submission experts, allowed us to cut our publishing time for a full New Drug Application in half. Rework was minimized, allowing us to meet aggressive timelines. Customer service responsiveness is top-notch. Celegence is the best business partner we’ve had in our 25 years. We managed to publish a full NDA with a very aggressive timeline; we have successfully submitted it to the FDA just 12 working days after we started publishing the first set of documents. A total of 645 PDF files have been published, 450 dataset files have been included, and almost 2000 hyperlinks have been created in this dossier. The submission itself has been reviewed by the customer directly in Dossplorer, which was a key solution with this challenging timeline.