• Expert in development, regulatory and market access.

    We assist companies, of all sizes, with all aspects of their development plans through to gaining regulatory approval and market access.

Since 1994, we have helped our clients achieve development milestones and regulatory approval for their products in over 90 countries around the world.
How we can help you

Strategic
Advice

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Pharmaceutical Development

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Preclinical Development

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Clinical Development

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Project Management

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Regulatory Strategy & Implementation

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Pharmacovigilance

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Auditing

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Market Access

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Portfolio Analysis and Life Cycle Management

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Due Diligence

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Quality Management

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A single point of contact for all of your development, regulatory and market access needs.

Dr. Regenold GmbH

Dr. Regenold GmbH is specialised in development, international regulatory affairs and market access. Founded in 1994, Dr. Regenold GmbH has helped many clients progress their product developments, by providing scientific and regulatory advice, through to gaining regulatory approval and marketing authorisations both nationally and internationally.

Recognising clients’ needs for pan-European and global product registrations, Dr. Regenold founded regulanet®, a network of regulatory affairs consultancies with members in over 90 countries throughout the world. Established in 2001, member companies offer services to a wide variety of national and international healthcare and pharmaceutical clients, helping them understand the complexities of the different regulatory and market access requirements and providing solutions.

Dr. Regenold GmbH expertise covers development, regulatory affairs and market access. Our aim is to help clients maximise the value of their product or device throughout its development and lifecycle within a constantly evolving regulatory and market access environment. We do this by developing innovative and cost effective development and regulatory strategies and solutions, tailored to the client, to achieve set milestones and thereby optimise regulatory approval and market access. Our product expertise includes Medicines (Prescription and OTC), Biopharmaceuticals, Orphan drugs, Medical Devices, In Vitro Diagnostics, Combination products, Borderline products, Food Supplements, Cosmetics and Chemicals. In response to client feedback and demand, we have expanded our services beyond product development , scientific advice and regulatory to include Market Access, Portfolio Analysis and Life Cycle Management.

By gaining an understanding of clients’ commercial needs, the key decision makers and route to market, Dr. Regenold GmbH is able to recommend development, regulatory and market access solutions which help clients achieve their milestones and bring their products efficiently to market.

How we can help