regenold GmbH
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      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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    • Focus Areas:

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      • 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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regenold GmbH
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Headquarters:
regenold GmbH
Zöllinplatz 4
79410 Badenweiler
Germany

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

  1. Home
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Our Industry Associations

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Working Together to Shape the Future of Life Sciences

Regulatory requirements and best practices change. Guidances get revised, frameworks get replaced, interpretations are updated. Keeping up is a key aspect of the job. We stay close to the industry and professional bodies in our fields, across medicines, medical devices, IVDs, digital health, and food and cosmetics, so we keep working from the most current assumptions and practices.

The organisations below are among those we actively engage with.

Global Regulatory Network

regulanet®

regulanet® is a global network of independent regulatory affairs, clinical development, pharmacovigilance, quality, and market access experts operating in more than 90 countries. The network enables organisations to access trusted local expertise while maintaining consistent international project management and quality standards.

As the founder and coordinator of regulanet®, regenold combines global reach with in-country expertise, allowing us to support complex international regulatory programmes through a single point of contact while ensuring local compliance in each target market.

www.regulanet.com

Regulatory Affairs & Compliance

RAPS – Regulatory Affairs Professionals Society

RAPS is the world's largest organisation dedicated to regulatory professionals working in pharmaceuticals, medical devices, biotechnology, diagnostics, and related healthcare sectors.

www.raps.org

TOPRA

TOPRA is one of the world's leading professional organisations for regulatory affairs, supporting regulatory professionals through education, conferences, networking, publications, and professional development.

www.topra.org

ESRA – European Society of Regulatory Affairs

The European Society of Regulatory Affairs (ESRA) promotes excellence in regulatory affairs throughout Europe by supporting education, professional development, and collaboration between regulatory professionals working across the life sciences sector.

www.esra.org

DGRA – Deutsche Gesellschaft für Regulatory Affairs e.V.

DGRA is Germany's professional society dedicated to regulatory affairs for medicinal products, medical devices, and related healthcare products. It promotes education, scientific exchange, and the advancement of regulatory science.

www.dgra.de

MEGRA

MEGRA is Germany's professional association for medical writers and regulatory affairs specialists, promoting high standards in scientific communication, regulatory documentation, and professional education.

www.megra.org

Pharmaceutical Industry

Pharma Deutschland e.V.

Pharma Deutschland is one of Germany's largest pharmaceutical industry associations, representing manufacturers of prescription medicines, over-the-counter medicines, biopharmaceuticals, and healthcare products.

www.pharmadeutschland.de

DPhG – Deutsche Pharmazeutische Gesellschaft e.V.

The German Pharmaceutical Society (DPhG) promotes pharmaceutical science, education, and research by bringing together pharmacists, scientists, researchers, industry professionals, and academic institutions.

www.dphg.de

APV – Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.

APV is Germany's leading professional association for pharmaceutical engineering, manufacturing technology, and pharmaceutical process development. It promotes the exchange of scientific and technical knowledge across pharmaceutical production, quality assurance, validation, and process optimisation.

www.apv-mainz.de

Pharma Lizenz Club Deutschland (PLCD) e.V.

PLCD provides a specialised networking platform for pharmaceutical licensing, business development, strategic partnerships, and commercial collaboration across the pharmaceutical industry.

www.plcd.de

Kinderarzneimittel in Europa e.V.

Kinderarzneimittel in Europa e.V. is dedicated to improving the development and availability of safe, effective medicines for children by bringing together experts from industry, academia, healthcare, and regulatory authorities.

www.meds4kids.de

PAGB – The Consumer Healthcare Association

PAGB is the UK trade association representing manufacturers of over-the-counter (OTC) medicines, self-care medical devices, and food supplements. It promotes responsible self-care, supports high industry standards, and works with regulators to shape policies affecting consumer healthcare products.

www.pagb.co.uk

Ethical Medicines Industry Group (EMIG)

The Ethical Medicines Industry Group (EMIG) represents research-based and specialty pharmaceutical companies operating in the United Kingdom. The association works closely with government, regulators, and healthcare stakeholders to promote patient access to innovative medicines and a competitive UK life sciences sector.

www.emig.org.uk

Healthcare Distribution Association (HDA UK)

The Healthcare Distribution Association (HDA UK) represents pharmaceutical wholesalers and distributors responsible for supplying medicines and healthcare products throughout the United Kingdom. The association promotes secure, efficient, and compliant pharmaceutical distribution while supporting Good Distribution Practice (GDP) standards.

www.hdauk.com

Medical Devices & Digital Health

Medical Valley

Medical Valley is an internationally recognised healthcare innovation cluster bringing together companies, universities, hospitals, start-ups, and research institutions to accelerate medical innovation.

www.medical-valley-emn.de

MedicalMountains

MedicalMountains is one of Germany's leading MedTech innovation clusters, supporting medical device manufacturers through networking, education, regulatory expertise, and collaborative innovation projects.

www.medicalmountains.de

Med Alliance

Med Alliance is an expert initiative coordinated by MedicalMountains in which medical device manufacturers collaborate pragmatically on the practical implementation of regulatory requirements. Originating from an expert roundtable formed in response to the EU Medical Device Regulation, it brings companies together to share experience, knowledge, and practical solutions to common regulatory challenges.

medicalmountains.de/med-alliance

DiagnostikNet BB – Netzwerk Diagnostik Berlin-Brandenburg e.V.

DiagnostikNet BB is a regional innovation network that supports companies and research institutions working in in vitro diagnostics, molecular diagnostics, laboratory medicine, and medical technologies throughout the Berlin-Brandenburg region.

www.diagnostiknet-bb.de

SVDGV – Spitzenverband Digitale Gesundheitsversorgung e.V.

The German Digital Healthcare Association (SVDGV) represents companies developing digital health applications, digital therapeutics, connected healthcare solutions, and innovative healthcare technologies.

www.digitalversorgt.de

MPP – Medtech & Pharma Platform

MPP connects professionals across the pharmaceutical and medical technology industries through conferences, networking events, and educational initiatives that promote collaboration and knowledge sharing.

www.medtech-pharma.com

Biotechnology & Innovation

EuropaBio

EuropaBio is the leading European association representing the biotechnology industry. It advocates for policies that encourage innovation across healthcare biotechnology, industrial biotechnology, agricultural biotechnology, and sustainable bio-based solutions.

www.europabio.org

BIOVALLEY Basel

BIOVALLEY Basel is one of Europe's leading life sciences clusters, connecting pharmaceutical companies, biotechnology innovators, research institutions, healthcare organisations, and start-ups throughout the trinational region of Switzerland, Germany, and France.

www.biovalley.ch

One Nucleus

One Nucleus is a leading life sciences and healthcare membership organisation supporting biotechnology, pharmaceutical, medical technology, diagnostics, and digital health companies across the United Kingdom and internationally. It fosters collaboration, innovation, investment, and business growth through networking, events, and specialist programmes.

www.onenucleus.com

Medilink Midlands

Medilink Midlands is one of the UK's largest life sciences membership organisations, supporting companies operating in medical technology, pharmaceuticals, diagnostics, digital health, biotechnology, and healthcare services. The organisation promotes innovation through collaboration, networking, knowledge sharing, and business support.

www.medilinkmidlands.com

Food & Cosmetics

Lebensmittelverband Deutschland e.V.

Lebensmittelverband Deutschland is the leading organisation representing Germany's food industry, promoting science-based regulation, consumer protection, food safety, and responsible innovation.

www.lebensmittelverband.de

DGK – Deutsche Gesellschaft für Wissenschaftliche und Angewandte Kosmetik e.V.

DGK promotes scientific research, education, and professional exchange within cosmetic science, formulation development, safety assessment, and cosmetic regulation.

www.dgk-ev.de

Scientific Publishing & Knowledge

S. Karger AG

S. Karger AG is an internationally respected scientific and medical publishing company that supports the advancement of healthcare through peer-reviewed journals, books, and scientific communication.

www.karger.com

Behr's GmbH

Behr's GmbH is a specialist publisher and provider of professional knowledge for the food, pharmaceutical, healthcare, cosmetics, and consumer goods industries. Its publications, conferences, and training programmes support professionals working in quality, regulatory affairs, product safety, and compliance.

www.behrs.de

Business & Regional Networks

Devon Chamber of Commerce

Devon Chamber of Commerce is a regional business organisation that supports companies through networking, advocacy, business development, international trade services, and economic growth initiatives. As part of the British Chambers of Commerce network, it connects businesses across sectors throughout the South West of England.

www.devonchamber.co.uk

Industry Associations

  • Global Regulatory Network
  • Regulatory Affairs & Compliance
  • Pharmaceutical Industry
  • Medical Devices & Digital Health
  • Biotechnology & Innovation
  • Food & Cosmetics
  • Scientific Publishing & Knowledge
  • Business & Regional Networks

Get in Touch

Tell us where your product needs to be approved. We will outline how regenold and regulanet® would work together on your project. To browse the network directly, see regulanet.com.

Get in Touch
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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