# regenold GmbH

> regenold is a global, end-to-end integrated development partner for life sciences companies. Founded in 1994 and independently owned, regenold supports pharmaceuticals, medical devices, in vitro diagnostics, and drug-device combination products across the full product lifecycle — from preclinical development and regulatory strategy through to clinical development, market access, and post-approval lifecycle management. regenold operates from offices in Germany, UK, Ireland, Portugal, and Switzerland, and extends global reach to 90+ countries through its proprietary partner network, regulanet®. Track record includes 2,000+ clients, 10,000+ successful submissions, 45+ Marketing Authorisation Applications, and 40+ Scientific Advice procedures.

## About

- [Who We Are](https://regenold.com/about/who-we-are): Company background, history, offices, and values. Independently owned and family-led since 1994, with European headquarters in Badenweiler, Germany.
- [regulanet®](https://regenold.com/about/regulanet): regenold's global network of independent regulatory and market access experts, providing local expertise in 90+ countries across North America, LATAM, Europe, MENA, and Asia.
- [Careers](https://regenold.com/about/careers): Open positions and working culture at regenold.

## Solutions by Product Type

- [Pharmaceuticals](https://regenold.com/solutions/pharmaceuticals): End-to-end support for small molecules, including development, CMC, regulatory submissions, and lifecycle management.
- [Biologicals, Biosimilars & ATMPs](https://regenold.com/solutions/biologicals-biosimilars-and-atmps): Regulatory and development support for biological medicines, biosimilars, and advanced therapy medicinal products.
- [Medical Devices](https://regenold.com/solutions/medical-devices): MDR and IVDR compliance, CE marking, clinical/performance evaluation, and technical documentation.
- [In Vitro & Companion Diagnostics](https://regenold.com/solutions/in-vitro-and-companion-diagnostics): IVDR-compliant pathways for IVDs and companion diagnostics.
- [Digital Health & SaMD](https://regenold.com/solutions/digital-health-and-samd): Regulatory strategy and compliance for Software as a Medical Device and digital health products.
- [Combination Products](https://regenold.com/solutions/combination-products): Integrated support bridging pharma and medtech requirements, including primary mode of action assessments and drug-device combination regulatory strategy.
- [Borderline Products](https://regenold.com/solutions/borderline-products): Classification and regulatory pathway definition for borderline and unclear product categories.
- [Food & Cosmetics](https://regenold.com/solutions/food-and-cosmetics): Regulatory support for food supplements and cosmetics (also via nutracompliance.com).

## Services

### Regulatory Affairs
- [Regulatory Strategy & Operations](https://regenold.com/services/regulatory-strategy-and-operations): MAA, CTA, eCTD submissions, scientific advice, PIPs, Orphan Drug Designation, EU variations, Rx-to-OTC, and multi-region regulatory programmes across EMA, FDA, MHRA, and 90+ countries.
- [Regulatory Intelligence](https://regenold.com/services/regulatory-intelligence): Horizon scanning, regulatory monitoring, and intelligence services to keep clients ahead of evolving requirements.
- [Medical Device & IVD Regulatory Services](https://regenold.com/services/medical-device-and-ivd-regulatory-services): MDR/IVDR compliance, notified body management, technical documentation, and clinical evaluation reports.
- [Software as a Medical Device & Cybersecurity](https://regenold.com/services/software-as-a-medical-device-and-cybersecurity): SaMD classification, regulatory strategy, and cybersecurity compliance for digital health products.
- [Product Information, Labelling & Promotional Compliance](https://regenold.com/services/product-information-labelling-and-promotional-compliance): SmPC, PIL, labelling, and promotional material review and compliance.
- [Regulatory Compliance Roles & Legal Representation](https://regenold.com/services/regulatory-compliance-roles-and-legal-representation): EU Responsible Person, UK Responsible Person, PRRC, and local legal representative services.

### Development & Science
- [Preclinical Development](https://regenold.com/services/preclinical-development): Study design, CRO selection, and regulatory-aligned preclinical programme management.
- [Pharmaceutical Development & CMC](https://regenold.com/services/pharmaceutical-development-and-cmc): Formulation, manufacturing, analytical development, and CMC regulatory documentation.
- [Clinical Development](https://regenold.com/services/clinical-development): Clinical strategy, protocol design, CTA submissions, and clinical programme management.
- [Medical & Scientific Writing](https://regenold.com/services/medical-and-scientific-writing): CTD modules, clinical study reports, investigator brochures, and regulatory documents.

### Quality, Compliance & Data
- [Quality & Compliance](https://regenold.com/services/quality-and-compliance): QMS design and implementation, GxP compliance, audit support, and CAPA management.
- [Risk Management & Human Factors](https://regenold.com/services/risk-management-and-human-factors): ISO 14971 risk management, human factors engineering, and usability studies.
- [AI Governance & Compliance](https://regenold.com/services/ai-governance-and-compliance): EU AI Act compliance, AI risk classification, and governance frameworks for regulated life sciences applications.
- [Data Protection & Information Security](https://regenold.com/services/data-protection-and-information-security): GDPR compliance, data protection impact assessments, and information security for life sciences.

### Pharmacovigilance & Safety
- [Pharmacovigilance & Device Vigilance](https://regenold.com/services/pharmacovigilance-and-device-vigilance): EU QPPV services, PSUR/PBRER preparation, signal detection, and device vigilance systems under MDR/IVDR.

### Commercial & Lifecycle
- [Market Access & HTA Strategy](https://regenold.com/services/market-access-and-hta-strategy): Health technology assessment strategy, payer evidence planning, and market access across European markets.
- [Post-Approval & Lifecycle Management](https://regenold.com/services/post-approval-and-lifecycle-management): Variations, renewals, label updates, and ongoing regulatory maintenance across markets.
- [Due Diligence Support](https://regenold.com/services/due-diligence-support): Regulatory and development due diligence for M&A, licensing, and partnership transactions.
- [Strategic Advice](https://regenold.com/services/strategic-advice): Senior-level regulatory and development strategy for complex or novel products and situations.

## Focus Areas

- [Pharmaceutical Development](https://regenold.com/focus-area/pharmaceutical-development): Coordinating science, manufacturing, and regulatory strategy for pharma products.
- [Medical Devices & IVDs](https://regenold.com/focus-area/medical-devices-and-ivds): Navigating design, evidence, and conformity assessment under MDR and IVDR.
- [Digital Health & SaMD](https://regenold.com/focus-area/digital-health-and-samd): Regulatory pathways for software-driven health products.
- [AI in Regulated Life Sciences](https://regenold.com/focus-area/ai-in-regulated-life-science): Navigating the EU AI Act and AI integration in regulated pharma and medtech environments.
- [Due Diligence](https://regenold.com/focus-area/due-diligence): Regulatory and development assessments supporting investment and partnership decisions.
- [Entry into Europe](https://regenold.com/focus-area/entry-into-europe): Market entry strategy and execution for non-European companies seeking EU approval and access.

## Resources

- [Resources & Insights](https://regenold.com/resources): Expert articles from regenold specialists covering MDR, IVDR, ISO-IDMP, clinical trial reform, SaMD, market access, pharmacovigilance, and more.

## Regional Pages

- [regenold UK](https://regenold.com/uk/): UK-specific regulatory services including UK Responsible Person and MHRA submissions.
- [regenold Ireland](https://regenold.com/ie/): Irish market regulatory support and HPRA-related services.
- [regenold Portugal](https://regenold.com/pt/): Portuguese market regulatory and development support.

## Contact

- **Headquarters:** regenold GmbH, Zöllinplatz 4, 79410 Badenweiler, Germany
- **Phone:** +49 7632 82 26-0
- **Email:** info@regenold.com
- **LinkedIn:** https://www.linkedin.com/company/regenold-gmbh/