Celegence

AI in regulatory affairs—an area where Celegence excels. At Celegence, our Tech-Enabled Services approach, powered by CAPTIS? AI, goes beyond automation, driving efficiency and optimizing business processes for medical device and pharmaceutical companies. This unique blend of technology and expertise sets us apart from other vendors, offering a seamless path to streamlined regulatory submissions. Unlike traditional Regulatory Affairs services, our focus on AI-driven optimization—such as automating CMC Module 3 for 50%+ efficiency gains—empowers companies to stay ahead in a competitive landscape. Join the leaders revolutionizing compliance and R&D with Celegence. #Tech-Enabled Services

Novo Nordisk A/S, the maker of Ozempic, has reduced clinical study report drafting time from 15 weeks to under 10 minutes using #AI. This demonstrates that AI is now advanced enough to create highly complex and sensitive #regulatory documents with precision. At Celegence, we see this impact firsthand. CAPTIS? AI is revolutionizing medical and technical writing, delivering: ??30% faster Clinical Evaluation Report (CER) creation ??60% reduction in systematic literature review time ??AI-driven precision and compliance for regulatory teams Beyond regulatory submissions, we’ve partnered with top-5 pharma clients to develop R&D-specific AI solutions. By integrating Retrieval-Augmented Generation (RAG) and automating #CMC Module 3, we’re targeting 50%+ efficiency gains in pharmaceutical submissions. ? Join leading #medicaldevice and #pharmaceutical companies adopting AI for regulatory writing and healthcare development: the future of compliance is AI-powered. ? ?? Book a demo of CAPTIS? AI: https://lnkd.in/e__vshzE ?? Source: https://lnkd.in/eqRpZ4Kc ? #AIinRegulatoryAffairs #MedicalWriting #RegulatoryCompliance #CAPTISAI #PharmaTech #ClinicalEvaluationReports #MedicalDevices

Strength isn’t just about overcoming hardships - it’s about building something meaningful while staying true to who you are. As part of our #VoicesOfStrength initiative for #InternationalWomensDay 2025, we are sharing stories of women whose dedication has shaped lives and communities. Lakshmi Priya Moturi, Medical Writer II, shares the story of her sister, Jahnavi Moturi, who turned her passion for art into a thriving platform while balancing a demanding corporate career. From teaching herself to paint to creating opportunities for young artists, she has shown that passion and profession can coexist. Let’s celebrate the women who inspire others through creativity and perseverance. #AccelerateAction #IWD2025 #WomenInLeadership #Resilience #Diversity #Strength

1 Week to Go! Are You Ready to Simplify Systematic Literature Reviews? #Medicaldevice professionals, don’t let inefficient SLR workflows slow down your compliance process! Join us next week on March 18, 2025, as our expert speakers dive into #regulatory challenges and technology-driven solutions for efficient, accurate, and structured literature reviews. ?????? ?????????????? ?? Master #NotifiedBody expectations for Literature Search Reports (LSRs)? ?? See how automation & GenAI tools like CAPTIS? can revolutionize #regulatorydocumentation? ?? Gain practical strategies for managing data-heavy literature reviews ?? March 18, 2025 | 10:00 AM EST? ?? Speakers: Parvathi Nambiar & Kasturi Rao? ?? Can’t attend live? All registrants will receive the webinar recording! ?? Register Now: https://lnkd.in/gSER2YnE #RegulatoryAffairs #MedicalDevices #MedTech #SLR #GenAI #AI #SystematicLiteratureReview #Automation #Webinar

The greatest acts of strength are often the quietest - shown through sacrifice, dedication, and unwavering love. As part of our #VoicesOfStrength initiative for #InternationalWomensDay 2025, we are honoring the women who dedicate themselves to creating better futures for those they love. Sonali Mohapatra, Medical Writer I, reflects on the sacrifices her mother made to raise her children. Through hardship, exhaustion, and personal challenges, she remained a steady presence, ensuring that her family had the support they needed to succeed. Let’s take a moment to recognize the women who shape lives through love and commitment. #AccelerateAction #IWD2025 #WomenInLeadership #Resilience #Diversity #MothersLegacy

?? Time is running out—join us tomorrow for the ATMP regulatory webinar ?? Are regulatory challenges slowing down your CGT approvals? Tomorrow, regulatory experts will break down the most pressing compliance issues affecting ATMPs and how to overcome them. ?? Live Q&A with experts? ?? Real-world strategies for faster ATMP approvals? ?? Actionable insights to streamline regulatory documentation ?? March 12, 2025 | 10:00 AM ET? ?? Maurice Bancsi & Kattia Lonsdale ?? Bonus: Can’t attend live? All registrants will receive a copy of the recording! ?? Act now—register before it’s too late: https://lnkd.in/gUmfXfmY #RegulatoryAffairs #GeneTherapy #CellTherapy #PharmaRegulations #ATMP #Webinar

Progress comes from those who are willing to learn, evolve, and lead by example. As part of our #VoicesOfStrength initiative for #InternationalWomensDay 2025, we are sharing stories of women who have embraced change and used it to shape a better future. Prasanna Lakshmi Koka, Senior Technical Writer, honors the legacy of her late grandmother, Koka Jhanaki Bhai, who demonstrated that learning has no age limit. From handling household finances to adapting to new technology at 88, she proved that curiosity and adaptability are lifelong strengths. Let’s celebrate the women who lead through learning and growth. #AccelerateAction #IWD2025 #WomenInLeadership #Resilience #Diversity #Innovation

At Celegence, we recognize that leadership is not just about titles - it’s about the values, dedication, and quiet strength that shape lives. As part of our #VoicesOfStrength initiative for #InternationalWomensDay 2025, we are sharing stories of women whose impact goes beyond recognition, demonstrating leadership in the way they live every day. Dr. Pratibha Mishra, Senior Manager - Medical Device Services, pays tribute to her mother, Mrs. Kiran Mishra, a woman who has exemplified resilience, knowledge, and integrity in every aspect of life. Though she never sought a corporate position, she instilled in her family the importance of commitment, curiosity, and leading with compassion. Her lessons in perseverance, excellence, and empathy have shaped Dr. Pratibha’s own leadership journey, proving that true leadership begins at home. Let’s celebrate the women who lead by example, shaping the world through their values and actions. #AccelerateAction #IWD2025 #WomenInLeadership #Resilience #Diversity #Strength #Leadership

At Celegence, we recognize that strength is often shown through quiet sacrifices, perseverance, and the ability to create opportunities despite challenges. As part of our #VoicesOfStrength initiative for #InternationalWomensDay 2025, we are sharing stories of incredible women who have shaped lives through their dedication and determination. Koushik Chakraborty, Associate II - Publishing & Submission, reflects on his mother’s remarkable journey - from taking on responsibilities at a young age to ensuring a better future for her family. Her resilience and commitment continue to inspire him every day. Let’s honor the women who redefine strength through their love, dedication, and perseverance. #AccelerateAction #IWD2025 #WomenInLeadership #Resilience #Diversity #Strength #MothersLegacy

At Celegence, we believe that strength is demonstrated through perseverance, guidance, and the impact we have on others. As part of our #VoicesOfStrength initiative for #InternationalWomensDay 2025, we are sharing stories of women whose dedication has shaped lives in meaningful ways. Vasupradha S.H, Junior Associate - Medical Device Services, shares how her mother became the driving force behind her achievements. From excelling in academics to competing as a National-Level Softball player, she learned that success is built on consistency and determination. Her mother’s guidance and encouragement not only shaped her journey but also reinforced the importance of leading by example. Let’s celebrate the women who push us to strive for more and show us the power of dedication. #AccelerateAction #IWD2025 #WomenInLeadership #Resilience #Diversity #Strength