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

      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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regenold GmbH
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Headquarters:
regenold GmbH
Zöllinplatz 4
79410 Badenweiler
Germany

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

  1. Home
  2. Privacy Policy

Privacy Policy

Effective as of: 05.05.2026

1. Data Controller and Data Protection Officer

The controller within the meaning of Article 4(7) of the GDPR is:

regenold GmbH
Zöllinplatz 4, D-79410 Badenweiler, Germany
Tel.: +49 7632 8226-0  |  Fax: +49 7632 8226-555
Email: Email
Web: https://regenold.com

2. General Information – Scope and Principles

We process personal data exclusively in accordance with the provisions of the GDPR, the BDSG, and other applicable data protection regulations. Personal data refers to any information relating to an identified or identifiable natural person (Art. 4(1) GDPR).

To the extent that we obtain consent for processing operations, the legal basis is Article 6(1)(a) of the GDPR in conjunction with Article 7 of the GDPR. To the extent that processing is necessary for the performance of a contract or for the implementation of pre-contractual measures, it is based on Article 6(1)(b) of the GDPR. In all other cases, we base processing—in particular for technical provision and IT security—on Article 6(1)(f) of the GDPR (legitimate interest).

3. Provision of the Website / Hosting / Server Log Files

3.1 Scope of Processing

When you visit our website, your browser transmits certain information to our server for technical reasons. This information is temporarily stored in log files. In particular, the following are recorded:

  • IP address of the requesting device
  • Date and time of access
  • URL/page accessed
  • Browser type/version, other browser-related information
  • Operating system and version
  • Amount of data transferred and access status
  • Language and version of the browser software

3.2 Purposes

The processing serves:

  • the technical delivery of the website,
  • to ensure IT security (e.g., detection of misuse or attacks).

3.3 Legal Basis

We base the processing on Article 6(1)(f) of the GDPR (legitimate interest in a secure, functional website).

3.4 Retention Period

Log files are deleted after seven days at the latest, unless longer retention is exceptionally required for the investigation or preservation of evidence regarding security incidents.

4. Cookies, Consent Management, and Consent

Depending on the specific function, we use both technically necessary technologies and those requiring consent (particularly analytics/marketing). We only use technologies requiring consent after you have given your explicit consent (opt-in).

4.1 Legal Basis

  • Technically necessary: Art. 6(1)(f) GDPR (legitimate interest).
  • Analysis/Marketing: Section 25(1) TDDDG (consent).

4.2 Withdrawal / Modification of Consent

You may withdraw your consent at any time with future effect (see Section 13 below). If a consent tool is used, you can adjust your settings there at any time.

5. Web Analytics – Matomo

We use the web analytics service Matomo on our website, an open-source software for the statistical analysis of visitor traffic. We operate Matomo either on our own servers or with a provider within the European Union, ensuring that data processing is entirely under our control.

As part of web analytics, the following data in particular is processed: truncated or anonymized IP addresses, pages visited, referrer URLs, device and browser information, as well as the date and time of the page visit. This data is not combined with other data sources.

The use of Matomo is based exclusively on your prior explicit consent in accordance with Art. 6(1)(a) GDPR in conjunction with Art. 7 GDPR and § 25(1) TDDDG.

The processing serves the statistical analysis of user behavior, the optimization of our website, and the improvement of user-friendliness.

You may revoke your consent at any time with future effect by adjusting your cookie settings accordingly.

6. Contacting Us (Email)

When you contact us via email, the personal data you provide (e.g., email address, name, and the content of the message) will be processed.

The processing is carried out for the purpose of handling your inquiry and the associated communication.

The legal basis is Article 6(1)(f) of the GDPR, as we have a legitimate interest in the proper handling of inquiries. If the contact is aimed at concluding a contract or takes place within the framework of pre-contractual measures, Article 6(1)(b) of the GDPR also applies.

The data will be deleted as soon as your inquiry has been fully processed and there are no legal retention obligations to the contrary.

7. Online Appointment Bookings (Zeeg & HubSpot)

Zeeg

On our website, you have the option to schedule appointments with specific representatives of our company. For this purpose, we use a tool provided by Zeeg GmbH, Friedrichstraße 114 a, 10117 Berlin, Germany (hereinafter referred to as "Zeeg"). The use of this tool is subject to Zeeg's Terms and Conditions.

The information requested by Zeeg, such as your email address, is processed to complete and confirm the appointment booking. In addition, you have the option to provide further information.

To the extent that appointment bookings are made in the context of fulfilling a contract to which the data subject is a party, or for the implementation of pre-contractual measures taken at the data subject's request: Art. 6(1)(b) GDPR.

In all other cases, pursuant to Art. 6(1)(f) GDPR, it is in our overriding legitimate interest to offer those interested in our services a simple, straightforward, and accessible way to schedule appointments with specific contact persons at our company. The data will be deleted once the purpose no longer applies.

For more information on how Zeeg processes your data, please refer to Zeeg's Privacy Policy and its Declaration of Compliance with the General Data Protection Regulation.

HubSpot

We are using HubSpot, a service provided by HubSpot Ireland Ltd., 2nd Floor 30 North Wall Quay, Dublin 1, Ireland (hereinafter referred to as “HubSpot”), for online appointment booking. The personal data you provide during the booking process (e.g. your name and email address) are processed in order to arrange, confirm, and manage the appointment.

Where appointment bookings are made in the context of fulfilling a contract to which the data subject is a party, or for the implementation of pre-contractual measures taken at the data subject’s request, the legal basis is Art. 6(1)(b) GDPR. In all other cases, processing is based on our legitimate interest pursuant to Art. 6(1)(f) GDPR in offering those interested in our services a simple and convenient way to book appointments. Data will be deleted once the purpose for which it was collected no longer applies.

HubSpot is engaged as a data processor in accordance with Art. 28 GDPR. A valid data processing agreement is in place. For further information on how HubSpot processes your data, please refer to HubSpot’s Privacy Policy.

8. Newsletter Distribution (HubSpot and Odoo)

We use the HubSpot (HubSpot Ireland Ltd., Dublin) and Odoo systems to send and manage our newsletter. Both systems are used exclusively for managing recipient lists and sending the newsletter.

In this context, we process in particular your email address and—if provided—your name. No further analysis of user behavior (e.g., tracking or profiling for marketing purposes) takes place in connection with the newsletter distribution.

The use of HubSpot and Odoo is based exclusively on your consent pursuant to Art. 6(1)(a) GDPR in conjunction with Art. 7 GDPR.

Both providers are used as processors in accordance with Article 28 of the GDPR.

Your data will be stored for as long as your consent remains valid and will be deleted immediately upon revocation, provided that no statutory retention obligations preclude this.

9. Rights of Data Subjects

You have the following rights, provided the legal requirements are met:

  • Right of access (Art. 15 GDPR)
  • Rectification (Art. 16 GDPR)
  • Erasure (Art. 17 GDPR)
  • Restriction (Art. 18 GDPR)
  • Data portability (Art. 20 GDPR)
  • Objection (Art. 21 GDPR)

To exercise these rights, simply send a message to the contact information listed above or to data-protection@regenold.com.

10. Right to Object under Art. 21 GDPR

If data is processed on the basis of Art. 6(1)(f) GDPR, you may object at any time for reasons arising from your particular situation. We will then no longer process the data unless we can demonstrate compelling legitimate grounds for doing so.

If personal data is processed for direct marketing purposes, you have the right at any time to object to the processing for the purpose of such marketing.

11. Withdrawal of Consent

Consent that has been given may be withdrawn at any time with effect for the future. The lawfulness of the processing carried out prior to the withdrawal remains unaffected (Art. 7(3) GDPR).

12. Data Security

We implement appropriate technical and organizational security measures (Art. 32 GDPR) to protect your data against accidental or intentional manipulation, loss, destruction, or unauthorized access. These include, in particular, access restrictions, authorization concepts, and state-of-the-art encryption techniques (e.g., TLS/SSL).

13. Right to Lodge a Complaint with a Supervisory Authority

You have the right to lodge a complaint with a data protection supervisory authority, in particular in the Member State of your habitual residence, your workplace, or the place of the alleged infringement (Art. 77 GDPR).

14. Supplementary Data Protection Information for Customers/Business Partners

Supplementary data protection notices may apply to certain processing situations (e.g., customer/partner relationships).

15. Validity and Changes to This Privacy Policy

We reserve the right to amend this Privacy Policy to adapt it to changes in the legal landscape, technical changes, or new services. The currently valid version applies.

Page Contents

  • 1. Data Controller
  • 2. Scope and Principles
  • 3. Hosting / Server Log Files
  • 4. Cookies and Consent
  • 5. Web Analytics – Matomo
  • 6. Contacting Us
  • 7. Online Appointment Bookings
  • 8. Newsletter Distribution
  • 9. Rights of Data Subjects
  • 10. Right to Object
  • 11. Withdrawal of Consent
  • 12. Data Security
  • 13. Right to Lodge a Complaint
  • 14. Supplementary Information
  • 15. Validity and Changes
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 •