regenold GmbH
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    • By Product Type:

      • Pharmaceuticals
      • Biologicals, Biosimilars & ATMPs
      • Medical Devices
      • In Vitro & Companion Diagnostics
      • Digital Health & SaMD
      • Combination Products
      • Borderline Products
      • Food & Cosmetics

      Keep Your Drug-Device Combination Products Variation-Ready

      We’ve experienced, that even long established drug–device combinations can fall short of current regulatory data expectations—putting variations at risk. We support you in assessing and strengthening your DDC data package to ensure robust, compliant submissions.

      DDC Variation Readiness

      EU Submission Readiness for Global Pharma

      Avoid Late Surprises in Your EU Submission. FDA approval is not a guarantee of EU readiness. European regulators apply different expectations for data, documentation, and operational infrastructure. Many US companies encounter gaps that lead to delays, rework, or regulatory friction.

      EU Readiness Checks

      Pharmacovigilance Audit Readiness & Survival Checklist

      Stress-test your pharmacovigilance system readiness across all 13 core inspection areas — and identify gaps before regulators do.

      Checklist
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    • Regulatory Affairs:

      • Regulatory Strategy & Operations
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      • Software as a Medical Device & Cybersecurity
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      • Regulatory Compliance Roles & Legal Representation

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      • Preclinical Development
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      • Clinical Development
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      Quality, Compliance, & Data:

      • Quality & Compliance
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      • AI Governance & Compliance
      • Data Protection & Information Security

      Pharmacovigilance & Safety:

      • Pharmacovigilance & Device Vigilance

      Commercial & Lifecycle:

      • Market Access & HTA Strategy
      • Post-Approval & Lifecycle Management
      • Due Diligence Support

      Strategic Advisory:

      • Strategic Advice
  • Focus Areas
    • Focus Areas:

      • Pharmaceutical Development
      • Medical Devices & IVDs
      • Digital Health & SaMD
      • AI in Regulated Life Sciences
      • Due Diligence
      • Entry into Europe
      • Food & Cosmetics → nutracompliance.com

      Keep Your Drug-Device Combination Products Variation-Ready

      We’ve experienced, that even long established drug–device combinations can fall short of current regulatory data expectations—putting variations at risk. We support you in assessing and strengthening your DDC data package to ensure robust, compliant submissions.

      DDC Variation Readiness

      EU Submission Readiness for Global Pharma

      Avoid Late Surprises in Your EU Submission. FDA approval is not a guarantee of EU readiness. European regulators apply different expectations for data, documentation, and operational infrastructure. Many US companies encounter gaps that lead to delays, rework, or regulatory friction.

      EU Readiness Checks

      Pharmacovigilance Audit Readiness & Survival Checklist

      Stress-test your pharmacovigilance system readiness across all 13 core inspection areas — and identify gaps before regulators do.

      Checklist
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Contact

We're here to help answer any questions you might have. We look forward to hearing from you.

regenold GmbH
Arrange a Call

Headquarters:
regenold GmbH
Zöllinplatz 4
79410 Badenweiler
Germany

Phone: +49 7632 82 26-0
Email: Email Us

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Events

We attend the main life sciences conferences across Europe, the US and South East Asia, both to stay up to date and to connect with existing and new clients. The list below shows where you can meet us over the coming months. To arrange a conversation at any of them, use the meeting request buttons below or reach out directly.

Agentic AI in Digital Therapeutics: From Clinical Innovation to European Market Approval

9 September 2026 | Online Webinar | 14:00 CEST

Join WELT Corp and regenold for a 60-minute live webinar exploring how adaptive, AI-enabled digital therapeutics can move from clinical innovation to compliant European market access. Using WELT’s DrugOS platform and SleepQ as practical examples, our experts will examine Software as a Medical Device classification, MDR and EU AI Act requirements, and regulatory strategies for digital and medicinal combination products.

Register Now

Medtech + Pharma Platform (MPP) Annual Conference 2026

22 September 2026 | Basel, Switzerland

We're attending to connect with the medicines development community, share experiences and keep up to date with the latest thinking across regulatory affairs. It's a great opportunity to learn from peers and strengthen existing relationships.

Request a Meeting Find out more

8th Drug-Device Combination Products Summit

22 to 24 September 2026 | Amsterdam, the Netherlands

Combination products continue to evolve, bringing new regulatory challenges and opportunities. We're looking forward to learning from industry experts, exchanging experiences and exploring how best to support clients developing these increasingly complex products.

Request a Meeting Find out more

World Patient Safety Congress

14 to 15 October 2026 | Boston, USA

Patient safety is central to everything we do. We're heading over to the US to explore the latest advances in pharmacovigilance, AI and safety monitoring, and going to make contacts that are also committed to improving patient outcomes across the globe.

Request a Meeting Find out more

TOPRA Symposium

19 to 21 October 2026 | Utrecht, the Netherlands

TOPRA is one of the highlights of the regulatory affairs calendar. We attend every year to stay at the forefront of regulatory developments, share knowledge with our peers and strengthen relationships across the life sciences community.

Request a Meeting Find out more

V. Arbeitskreis Zulassung – 73. Sitzung (Medac)

5 to 6 November 2026 | Hamburg, Germany

This meeting provides an excellent opportunity to discuss current regulatory developments with experienced professionals. We always come away with valuable insights that help us navigate an evolving European regulatory landscape.

Genesis 2026

10 December 2026 | London, UK

Genesis brings together the organisations shaping the future of life sciences. We're looking forward to meeting innovative companies, understanding their challenges and exploring how our expertise can help turn new ideas into successful healthcare products.

Request a Meeting Find out more

Dezentrale Verfahren und nationale Besonderheiten (Forum Institute Seminar)

14 December 2026 | Heidelberg, Germany

We're attending to deepen our understanding of decentralised procedures and national regulatory requirements across Europe. Sharing knowledge and practical experiences at events like this helps us deliver informed, pragmatic support to our clients.

Request a Meeting Find out more

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regenold GmbH

regenold is a global, end-to-end integrated development partner for pharmaceuticals, medical devices, and drug-device combination products. We support life sciences companies across the entire product lifecycle, delivering integrated development, regulatory, and market access expertise to enable efficient, compliant advancement from concept to market.

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regenold GmbH
Zöllinplatz 4
79410 Badenweiler
Germany

Phone: +49 7632 82 26-0
Email: info@regenold.com

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