regenold GmbH
  • Solutions
    • 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

      SPOTLIGHT: EU AI Act Q&A Competition

      From May to June 2026, we are hosting the first competition to assess the ability of AI agents to answer truthfully, concisely, and effectively to questions of the AI Act.

      AI Act Competition
  • Services
    • Regulatory Affairs:

      • Regulatory Strategy & Operations
      • Regulatory Intelligence
      • Medical Device & IVD Regulatory Services
      • Software as a Medical Device & Cybersecurity
      • Product Information, Labelling & Promotional Compliance
      • Regulatory Compliance Roles & Legal Representation

      Development & Science:

      • Preclinical Development
      • Pharmaceutical Development & CMC
      • Clinical Development
      • Medical & Scientific Writing

      Quality, Compliance, & Data:

      • Quality & Compliance
      • Risk Management & Human Factors
      • 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

      SPOTLIGHT: EU AI Act Q&A Competition

      From May to June 2026, we are hosting the first competition to assess the ability of AI agents to answer truthfully, concisely, and effectively to questions of the AI Act.

      AI Act Competition
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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
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Headquarters:
regenold GmbH
Zöllinplatz 4
79410 Badenweiler
Germany

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

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Impressum / Legal Notice

regenold GmbH
Zöllinplatz 4
D-79410 Badenweiler

Registergericht / Registry court: Amtsgericht Freiburg im Breisgau
Registernummer / Register number: HRB 300533

Umsatzsteuer-Identifikationsnummer gemäß §27a UStG / VAT-ID number according to § 27a UStG: DE166269501

Geschäftsführung / Managing Directors:
Dr. Maximilian Regenold, Bernd Schuler, Dr. Katrin Wiemann

Kontakt / Contact:
Tel.: +49 7632 82260
Fax: +49 7632 8226-555
E-Mail: Email

Haftung / Disclaimer:

Wir sind für die Inhalte unserer Internetseiten und digitaler Dienste nach den Maßgaben der allgemeinen Gesetze verantwortlich. Alle Inhalte werden mit der gebotenen Sorgfalt und nach bestem Wissen erstellt, dennoch können Fehler nicht gänzlich ausgeschlossen werden. Die veröffentlichen Inhalte dienen der Information über unser Unternehmen und unsere Leistungen. Wir sichern nicht zu, dass sich diese für bestimmte Zwecke eignen. Soweit wir auf unseren Internetseiten/digitalen Diensten mittels Hyperlink auf Internetseiten Dritter verweisen, können wir ebenfalls keine Gewähr für die fortwährende Aktualität, Richtigkeit und Vollständigkeit der verlinkten Inhalte übernehmen, da diese Inhalte außerhalb unseres Verantwortungsbereichs liegen und wir auf die zukünftige Gestaltung keinen Einfluss haben. Sollten aus Ihrer Sicht Inhalte gegen geltendes Recht verstoßen oder unangemessen sein, teilen Sie uns dies bitte mit. Die rechtlichen Hinweise auf dieser Seite sowie alle Fragen und Streitigkeiten im Zusammenhang mit der Gestaltung dieser Internetseite unterliegen dem Recht der Bundesrepublik Deutschland.

We are responsible for the content of our websites and digital services in accordance with the provisions of general law. All content is created with due care and to the best of our knowledge, however, errors cannot be completely excluded. The published content is intended to provide information about our company and our services. We do not guarantee that it is suitable for specific purposes. Insofar as we refer to third-party websites on our websites/digital services by means of hyperlinks, we also cannot guarantee that the linked content is always up-to-date, correct and complete, as this content is outside our area of responsibility and we have no influence on its future design. If you consider any content to be in breach of applicable law or inappropriate, please let us know. The legal information on this page and all questions and disputes in connection with the design of this website are subject to the law of the Federal Republic of Germany.

Urheberrechte / Copyrights:

Die von uns verwendeten Texte, Bilder, Fotos, Videos oder Grafiken unterliegen in der Regel dem Schutz des Urheberrechts. Jede unberechtigte Verwendung (insbesondere die Vervielfältigung, Bearbeitung oder Verbreitung) dieser urheberrechtsgeschützten Inhalte ist daher untersagt. Wenn Sie beabsichtigen, diese Inhalte oder Teile davon zu verwenden, kontaktieren Sie uns bitte im Voraus unter den obenstehenden Kontaktdaten. Soweit wir nicht selbst Inhaber der benötigten urheberrechtlichen Nutzungsrechte sein sollten, bemühen wir uns, einen Kontakt zum Berechtigten zu vermitteln.

The texts, images, photos, videos or graphics used by us are generally subject to copyright protection. Any unauthorised use (in particular the reproduction, editing or distribution) of this copyright-protected content is therefore prohibited. If you intend to use this content or parts thereof, please contact us in advance using the contact details above. If we are not ourselves the owner of the required copyright rights we will endeavour to arrange contact with the owner.

Page Contents

  • Impressum / Legal Notice
  • Haftung / Disclaimer
  • Urheberrechte / Copyrights
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

© 2026 regenold GmbH. All Rights Reserved. • Impressum/Legal Notice • Datenschutzerklärung • Privacy Policy •