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CMC Technical Writing: Strengthening Change Control and Lifecycle Management

Blog Pharmaceutical

Pharmaceutical

CMC Technical Writing: Strengthening Change Control and Lifecycle Management

16 Dec, 2025

EUDAMED Becomes Fully Mandatory from 28 May 2026: What Medical Device & IVD Manufacturers Need to Know

Blog Medical Devices

Medical Devices

EUDAMED Becomes Fully Mandatory from 28 May 2026: What Medical Device & IVD Manufacturers Need to Know

08 Dec, 2025

CMC Technical Writing: A Critical Enabler During Product Development

Blog Pharmaceutical

Pharmaceutical

CMC Technical Writing: A Critical Enabler During Product Development

02 Dec, 2025

AI in Medical and Technical Writing: Moving Beyond the Hype to Real-World Impact

Blog Medical Devices

Medical Devices

AI in Medical and Technical Writing: Moving Beyond the Hype to Real-World Impact

20 Nov, 2025

What is a Service+Tech Model? – The Fastest Path to Integrating AI into Regulatory Operations

Blog Medical Devices

Blog Pharmaceutical

What is a Service+Tech Model? – The Fastest Path to Integrating AI into Regulatory Operations

11 Nov, 2025

From Spreadsheets to Strategic Assets: Key Takeaways from Our Regulatory Data Management Webinar

Blog Pharmaceutical

Pharmaceutical

From Spreadsheets to Strategic Assets: Key Takeaways from Our Regulatory Data Management Webinar

04 Nov, 2025

Sonia Veluchamy Named Among Crain’s Top Health Tech Leaders 2025

Company News

Media Coverage

Sonia Veluchamy Named Among Crain’s Top Health Tech Leaders 2025

28 Oct, 2025

Regulatory Approvals in Africa: Key Frameworks, Challenges, and Emerging Trends

Blog Pharmaceutical

Pharmaceutical

Regulatory Approvals in Africa: Key Frameworks, Challenges, and Emerging Trends

21 Oct, 2025

AI and Data Privacy & Compliance: How is Your Data Protected?

Blog Medical Devices

Blog Pharmaceutical

AI and Data Privacy & Compliance: How is Your Data Protected?

14 Oct, 2025

EU Fluorinated Greenhouse Gases Regulation: Guidance for Pharma Manufacturers

Blog Pharmaceutical

Pharmaceutical

EU Fluorinated Greenhouse Gases Regulation: Guidance for Pharma Manufacturers

08 Oct, 2025

Beyond Automation: How AI Transforms Clinical Evaluation Reports into Strategic Regulatory Assets

Blog Medical Devices

Medical Devices

Beyond Automation: How AI Transforms Clinical Evaluation Reports into Strategic Regulatory Assets

03 Oct, 2025

EU Regulatory Challenges and Considerations in Radiopharmaceuticals

Blog Pharmaceutical

Pharmaceutical

EU Regulatory Challenges and Considerations in Radiopharmaceuticals

24 Sep, 2025

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Clinical Evaluation Plan and Report of a Radiological Imaging Software​​

Medical devices

Clinical Evaluation Plan and Report of a Radiological Imaging Software​​

05 Dec, 2025

Literature Search Report (LSR) Support in Compliance with EU MDR

Medical devices

Literature Search Report (LSR) Support in Compliance with EU MDR

27 Nov, 2025

RIM System Migration for a Large Global Pharmaceutical Company

Pharmaceuticals

RIM System Migration for a Large Global Pharmaceutical Company

18 Nov, 2025

IDMP Preparation and PMS Data Management for a Large Pharmaceutical Company

Pharmaceuticals

IDMP Preparation and PMS Data Management for a Large Pharmaceutical Company

13 Nov, 2025

End-to-End RIM Data Management for a Large Pharmaceutical Company

Pharmaceuticals

End-to-End RIM Data Management for a Large Pharmaceutical Company

05 Nov, 2025

RIM Data Management & Compliance Support for a Mid-Sized Pharmaceutical Company

Pharmaceuticals

RIM Data Management & Compliance Support for a Mid-Sized Pharmaceutical Company

23 Oct, 2025

EU MDR compliance support for a Global Medical Device Manufacturer​

Medical devices

EU MDR compliance support for a Global Medical Device Manufacturer​

16 Oct, 2025

Australia TGA Compliance Support for a Dental Implant Device Manufacturer

Medical devices

Australia TGA Compliance Support for a Dental Implant Device Manufacturer

08 Oct, 2025

EU MDR Compliance Support for a Global Combination Product Manufacturer

Medical devices

EU MDR Compliance Support for a Global Combination Product Manufacturer

03 Oct, 2025

Ensuring xEVMPD Compliance for a Mid-Sized Pharmaceutical Company

Pharmaceuticals

Ensuring xEVMPD Compliance for a Mid-Sized Pharmaceutical Company

25 Sep, 2025

EU MDR compliance support for Tissue Perfusion Imaging Device​

Medical devices

EU MDR compliance support for Tissue Perfusion Imaging Device​

19 Sep, 2025

IDMP Data Readiness for a Mid-Sized Pharmaceutical Company

Pharmaceuticals

IDMP Data Readiness for a Mid-Sized Pharmaceutical Company

11 Sep, 2025

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Enhancing CMC/Module 3 Documentation with Gen AI Whitepaper

Enhancing CMC/Module 3 Documentation with Gen AI Whitepaper

Transforming Regulatory Processes Through Artificial Intelligence Pharmaceutical companies are under increasing pressure to produce structured, high-quality Chemistry, Manufacturing, and Controls (CMC) documentation often under tight timelines. Manual authoring of CMC/Module 3 content remains a bottleneck due to the sheer volume, complexity, and regulatory scrutiny involved. Celegence’s latest whitepaper explores how Generative AI is reshaping regulatory […]

EU MDR Checklist

EU MDR Checklist

Make Sure You’re EU MDR Compliant As regulatory specialists, we are aware of the burden you are probably under in making your medical device business compliant with the upcoming EU MDR which comes into force later this year. As part of our commitment to helping businesses make the transition, we have compiled a checklist which […]

EU IVDR Checklist

EU IVDR Checklist

Make Sure You’re EU IVDR Compliant As regulatory specialists, we are aware of the burden you are probably experiencing in making your In Vitro Diagnostic device compliant with the EU IVDR which comes into force next year. The EU IVDR affects all IVD medical devices and will bring about several major changes. As part of […]

Lean Authoring Checklist

Lean Authoring Checklist

Lean Authoring: Eliminating Redundancies And Complexities For The Pharmaceutical Industry And Health Authorities

EU Scientific Advice Whitepaper

EU Scientific Advice Whitepaper

Download our exclusive report to streamline regulatory approvals and optimize your EU scientific advice strategy.

Regulatory Readiness and Resources Survey Report 2024

Regulatory Readiness and Resources Survey Report 2024

Get instant access to the survey report that regulatory professionals are talking about: the 2024 RAPS & Celegence Regulatory & Readiness Survey.

Medical Device Regulatory Survey Report 2024

Medical Device Regulatory Survey Report 2024

Be the first to explore pivotal findings that will shape the future of MedTech regulation. Our survey covered key topics such as current challenges, resource allocation, advanced technologies, and regulatory processes to provide a clear picture of where the industry is headed.

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    Austrian Agency for Health and Food Safety (AGES)

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    Agency for medicinal products and medical devices of Croatia (HALMED)

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    Ministry of Health – Pharmaceutical Services

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    State Agency of Medicines (Ravimiamet)

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    Finnish Medicines Agency (FIMEA)

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    National Agency for the Safety of Medicine and Health Products (ANSM)

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    German Institute of Medical Documentation and Information

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      • Event
      • Medical Devices
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      Future-Proof Your CERs for 2026: Meet Notified Body Expectations for Audit-Ready SLRs

      December 4, 2025

      Medical Devices

      Webinar

      Future-Proof Your CERs for 2026: Meet Notified Body Expectations for Audit-Ready SLRs

      M4Q(R2): The Road to Pragmatic, Modernized CMC Submissions

      November 20, 2025

      Pharmaceuticals

      M4Q(R2): The Road to Pragmatic, Modernized CMC Submissions

      Celegence at GPRAS Summit 2025: Driving AI-Powered Regulatory Innovation

      October 21, 2025 | Berlin, Germany

      Event

      Pharmaceuticals

      Celegence at GPRAS Summit 2025: Driving AI-Powered Regulatory Innovation

      Celegence at RAPS US Convergence 2025

      October 7, 2025 | Pittsburgh , Pennsylvania

      Event

      Medical Devices

      Pharmaceuticals

      Celegence at RAPS US Convergence 2025

      Beyond the Spreadsheet: The Silent Cost of Data Chaos in Regulatory Affairs

      September 2, 2025

      Pharmaceuticals

      Webinar

      Beyond the Spreadsheet: The Silent Cost of Data Chaos in Regulatory Affairs

      Getting MDR Clinical Evaluations Right: Practical Guidance for Dental Device Manufacturers

      June 26, 2025

      Medical Devices

      Webinar

      Getting MDR Clinical Evaluations Right: Practical Guidance for Dental Device Manufacturers

      Staying Compliant: Strategies for EU MDR and Beyond

      May 22, 2025 | Online

      Medical Devices

      Webinar

      Staying Compliant: Strategies for EU MDR and Beyond

      The Regulatory Landscape in 2025: What you need to know

      May 7, 2025 | Online

      Pharmaceuticals

      Webinar

      The Regulatory Landscape in 2025: What you need to know

      Celegence to Exhibit at MAPS Americas 2025 – Advancing AI in Medical Affairs

      March 26, 2025 | New Orleans

      Event

      Medical Devices

      Celegence to Exhibit at MAPS Americas 2025 – Advancing AI in Medical Affairs

      Overcoming Regulatory Challenges for Cell and Gene Therapy Products: Insights into ATMP Success

      March 12, 2025 | Online

      Pharmaceuticals

      Webinar

      Overcoming Regulatory Challenges for Cell and Gene Therapy Products: Insights into ATMP Success

      Regulatory Submissions, Information, and Document Management Forum (RSIDMF) 2025

      February 3, 2025 | North Bethesda , MD

      Event

      Pharmaceuticals

      Regulatory Submissions, Information, and Document Management Forum (RSIDMF) 2025

      Webinar – EU Pharmaceutical Reform: Unveiling Draft Legislation Impacts

      February 2, 2025 | Online

      Pharmaceuticals

      Webinar

      Webinar – EU Pharmaceutical Reform: Unveiling Draft Legislation Impacts

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