From idea to implementation

Management of your Development Project

We unlock your project’s potential, overcoming challenges and finding solutions along the road to success.

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Healthcare and related products

Regulatory Approval around the globe.

From strategy to implementation, our global regulatory experts will achieve successful commercialization and compliance for your product.

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Health Economics and reimbursement


We bring your products to market by quickly identifying clinical and economic needs, reimbursement strategies, and the best route to market.

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Regenold: Your Gateway to Global Regulatory Approval


Expertise in Every Aspect of Healthcare Product Success

That’s why we help companies of all sizes ensure that their development plans are designed and implemented for regulatory approval and market access.

We enjoy taking on ambitious projects and understanding your product’s challenges is the heart of what we do. Through listening and brainstorming, our experienced and motivated teams will always work to put the best solutions forward.

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Services tailored to fit all your needs

Our team is part of the world's most extensive network of professionals, composed of leading industry and academic experts in clinical medicine, biology, and pharmaceutical sciences.

Project design and implementation, risk mitigation, exploiting opportunities, resource allocation, project sustainability, and success evaluation criteria.

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Regulations and guidelines, market access requirements, regulatory strategy and implementation, evaluation of technical data, and regulatory authorities.

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Health economics, reimbursement strategies, key decision makers and stakeholders, market assessment, clinical and economic product benefits.

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Since 1994, we’ve helped clients achieve developmental milestones and regulatory approval in over 90 countries.

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Services and Product Expertise

Our goal is to help clients maximize the value and life cycle of their product amid a constantly-evolving regulatory environment. By developing innovative, tailored, and cost-effective strategies, we help our clients achieve milestones and cultivate the path to market access.

Meet our Teams
  • Strategic Advice
  • Pharmaceutical Development
  • Preclinical Development
  • Clinical Development
  • Project Management
  • Regulatory Strategy & Implementation
  • Pharmacovigilance
  • Market Access
  • Portfolio Analysis & Life Cycle Management
  • Due Diligence
  • QM Systems, Licenses & Compliance
  • Brexit
  • Medicines
  • Biopharmaceuticals
  • Orphan Drugs
  • Medical Devices
  • In Vitro Diagnostics
  • Combination Products
  • Companion Diagnostics
  • Borderline Products
  • Herbal & Traditional Herbal Medicines
  • Food Supplements
  • Cosmetics
  • Chemicals


regenold insights

Get regular, relevant updates on recent developments in regulatory affairs, pharmacovigilance and Digital Health innovation.

Urgent Support to Safeguard Your Borderline Product

Regulation (EU) 2023/607 addresses imminent risks of medical device shortages in the EU by extending transition timelines of Regulation 2017/745 EU (MDR) up to the end of 2027/2028, thereby allowing continues marketing off legacy devices based on previous MDD/AIMDD Certificates.

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regulanet®: The Network

Expertise in every country.

From development to market access, we help companies of all sizes ensure that their development plans are designed and implemented to gain regulatory approval and access to market in their chosen countries.

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