Our Core Work
We have spent more than thirty years helping clients to navigate the complexities of international drug and device registration in an ever-changing environment. We combine regulatory expertise, collaborative partnerships, and innovation to maximise approval success, accelerate market entry, and ensure healthcare solutions reach the patients who need them.
We help clients to build and implement a regulatory and development strategy and translate it into a clear and practical plan. We build the plan, we help execute the plan, we write the documents, we support authority interactions, we manage the submission, we help put the infrastructure in place, and we stay involved long after approval.
Where the work requires it, we also take on the local roles. We act as MAH, Responsible Person, or Authorised Representative for clients operating in markets where they do not have their own presence.
How We Work
Many clients approach us with the same underlying question: why are there so many complicated requirements and how do we get our products to patients without losing time and money? Regulation is built up over decades, across jurisdictions, for products that did not exist when the rules were written. Helping you navigate that is what we do.
Working in partnership with our clients is key; our job is to understand your challenges, constraints and opportunities. With those in mind we work with you to define and execute a robust and cost effective strategy, working flexibly to suit the business needs of every client. We can act as an extension of your own teams, we can flex resources up and down or we can provide consistent support and representation according to your needs.
Our services are truly end to end, covering every step from development to full lifecycle support, including regulatory, clinical, non-clinical, CMC, quality, QP, RP, and MAH/LM services, pharmacovigilance, and market access and distribution set-up. We are practical and pragmatic, and we bring a level of expertise that allows us to be honest with our clients; if a plan is unworkable, we say so. If a timeline is unrealistic, we flag it. If a dossier, study design, technical file, or authority strategy will not hold up, we will not dress it up.
In practice, an engagement with us usually moves through four steps:
1
Understand your situation, objectives and specific context of your product or project.
2
Explore possible strategies with their timelines and trade-offs.
3
Estimate the cost and resourcing of different strategies.
4
Work in partnership to implement the plan, securing a successful outcome.
Then we remain involved beyond initial delivery. Most of our client relationships run for years, spanning multiple projects, authority interactions, and the inevitable changes to data and the regulation.
What Defines Us
We create connectivity
Pharmaceutical development is multifaceted and success is defined by connectivity between different areas of expertise. Development does not happen in isolation; a regulatory decision affects CMC, a clinical design affects market access. A device classification can change the evidence plan. A quality issue can become a submission risk.
We bring the right areas of expertise together early, we build a connected and robust strategy from the start and we ensure that decisions are made with the bigger picture in mind. According to your needs we leverage regulatory, clinical, CMC, quality, pharmacovigilance, medical device, IVD, and market access input to connect around one project plan. This helps avoid late surprises, duplicated work, and strategies that look good in one area, but fail in another.
We are clear (even when the path forward is not)
Not every product fits neatly into an existing definition or accepted strategy; some development questions have a clear answer and others depend on the data, the claim, the authority, the country, the current environment or how the product is presented.
It is our job to separate those points. We explain what is clear, what is uncertain, what is evolving and what is open to debate and negotiation. We also say when an approach is unlikely to succeed, when more evidence is needed, or when authority input will help to clarify. This is often where our work matters most: when a project needs a route forward, but also an honest view of what might not work.
We do the work
Good advice only helps if there is a practical way to implement it. We have always been hands-on. We help build the plan, but we also help carry it out. We write the eCTD and technical documentation. We submit through the relevant agency portals. We respond to deficiency letters, prepare authority interactions, and support the follow-up. We set up pharmacovigilance systems and put QPPVs in place. We provide QP services, including batch certification where required. We support distribution set-up, including WDL and Responsible Person services.
Much of our know-how comes from doing this work every day, across projects, products, procedures, authorities, and countries. This is particularly valuable when a project does not follow the usual route.
We stay with the project
Many of our project and client relationships run over years. Products change, data evolves, authorities ask new questions, client teams change, but we keep the history of the project and carry it into the next decision.
Our teams are stable, and many colleagues have worked together for a long time. At the same time, we now have the breadth to support a product from early development through submission, approval, launch, and lifecycle management within one organisation. For you, that means less re-explaining, fewer handovers, and a team that understands both the history and the next step.
We simplify global projects leveraging our network of local expertise
Or as we usually call it: Local expertise. Global reach.
Global projects need people who understand country-specific requirements, know authority expectations, and can judge how things work in practice. This is difficult to build from the outside, especially when several markets are involved.
We work from our own offices in Germany, Austria, the UK, Ireland, Portugal, and Switzerland. Beyond that footprint, we use regulanet®, the international network we founded in 2001, to bring in the right expertise where needed. regulanet® gives access to independent regulatory, development, and market access specialists across more than 90 countries. They bring local knowledge, established authority experience, and practical understanding of country-specific requirements.
We coordinate that input for you. One project lead, one coordinated team, and one line of accountability. The right expertise is brought in where it matters, without leaving you to manage the complexity alone.
How We're Organised
We are organised around expert teams that come together as one project team. Most projects involve several subject matter experts. A typical setup includes one project lead and a small core team, with additional experts joining as needed and as the project evolves.
Where possible and where it makes sense, the same core team stays involved from planning through dossier writing, submission, authority questions, and lifecycle activities. That continuity matters, especially in complex or long-running programmes, and especially once a relationship with the authorities has been established.
Our teams:
Each team has its own page with more detail on how they work and what they deliver.
Management
Our management team has in-depth expertise and experience of the industries that we serve including pharmacy, drug development, regulatory affairs, medical devices, and life sciences investment. That experience is brought directly into the projects we work on and the clients we support. We have been independently owned and family-led since 1994, which means decisions are taken on the timescale of our clients' products, not an external shareholder's.
Dr. Jürgen Regenold — Founder and Chairman
Jürgen founded regenold in 1994, just as the new European routes to market authorisation were coming into operation. He saw what those pathways could open up for pharmaceutical companies, and he set up regenold around a single idea: companies need partners who help them understand the way through international drug development and registration, and who do the work alongside them, not advisors at arm's length. Three decades later, that conviction still defines how regenold operates.
A trained pharmacist with early-career research experience in CNS pharmacology, Jürgen built regenold's reputation through direct involvement in client programmes across pharmaceutical development, regulatory strategy, and authority interactions. In 1996 he began identifying regulatory experts in selected EU countries, and in 2001 he founded regulanet®, the international network that now connects regenold with independent development, regulatory, and market access specialists in more than 90 countries.
As Chairman, he sets the long-term direction of the firm and remains involved in strategic client work and partnership decisions.
Dr. Maximilian Regenold — CEO
Maximilian is regenold's Chief Executive Officer and the second generation of family leadership at the firm. He is responsible for ensuring that regenold continues to best serve our clients, leading the way in navigating drug and medical device development and utilising everything that regulatory pathways have to offer.
He is a pharmacist and pharmaceutical scientist. He trained in pharmacy at the University of Freiburg, holds a German pharmacist licence, and completed doctoral research at the Leslie Dan Faculty of Pharmacy, University of Toronto, on thermosensitive liposome formulations for triggered drug delivery in oncology.
He chairs regenold's engagement with new modalities including AI in regulated life sciences, and emerging therapeutic areas. He is a member of the Controlled Release Society.
Dr. Katrin Wiemann — COO
Katrin is regenold's Chief Operating Officer, and the senior leadership voice on how regenold delivers day to day, across teams, geographies, and disciplines. She has been part of the regenold team since 2023.
Katrin is an immunologist by training, with a doctorate from the University of Tübingen and a postdoctoral fellowship at Washington University in St. Louis. Her doctoral research on NKG2D regulation in cytotoxic lymphocytes continues to be frequently cited in tumour immunology literature today. She moved from research into industry in 2007, building businesses at the intersection of life sciences and technology: in medical devices at Fresenius Medical Care, and in healthcare software and digital health in successive product, integration, and general management roles.
She also holds an executive qualification in big data and artificial intelligence from the University of St. Gallen. That combination is reflected in regenold's active work on AI-enabled regulatory and quality systems for pharmaceutical and medical device manufacturers.
Bernie Schuler — CFO
Bernie has spent his career inside the life sciences industry: as an investor, a board member, and a strategic advisor across pharmaceuticals, medical devices, diagnostics, contract manufacturing, and laboratory services. He has seen what makes healthcare companies succeed and what breaks them, across a range that few CFOs in the consultancy space can match.
He brings that perspective directly into client work. When clients are weighing commercialisation strategy, partnership structures, in- and out-licensing decisions, or transaction readiness, Bernie is in the room with the operating team, actively contributing. His network across the European life sciences and healthcare ecosystem opens doors for regenold's clients on partnership and investment questions that sit alongside the technical and regulatory work.
Bernie formally joined the management team in 2025. As CFO, he anchors our financial and strategic direction in service of the long-term, independently owned model that defines regenold.
Roz Sutton — CEO regenold UK & Ireland
Roz leads regenold's UK and Ireland operations. She is the senior regenold contact for clients working through MHRA, HPRA, and EMA programmes, and the operational lead for our QP, RP, pharmacovigilance, and quality services delivered out of the UK and Ireland.
She has spent more than 25 years inside drug development organisations and consultancies, leading regulatory programmes for major pharmaceutical companies across neurosciences, oncology, and rare diseases. That work has included global regulatory strategies for accelerated approval pathways, FDA model-informed drug development pilot interactions, and the day-to-day grind of complex multi-region filings.
Roz holds a BSc in Pharmacology and a Certificate in Training Practice. She is a member of TOPRA and active in the wider regulatory affairs community.
Catarina Vieira — CEO regenold Portugal
Catarina founded and has led regenold's Portuguese operation since its founding in 2006. She is the senior contact for clients entering or operating in the Portuguese market.
A pharmacist by training, Catarina spent her early career on the operating side of the industry: first as a community pharmacist, then for eight years as Technical Director and Quality Assurance Representative at a Portuguese pharmaceutical logistics company. Across more than two decades of regulatory and quality work, she has handled marketing authorisation procedures, lifecycle activities, clinical trial applications, GMP and GDP audits, follow-up of EU agency inspections of third-country manufacturers, and Wholesale Distribution Licence applications.
She holds a degree in Pharmaceutical Sciences from the University of Coimbra and a postgraduate qualification in Regulation and Evaluation of Medicines and Health Products from the University of Lisbon.
Dr. Manuel Vögtli — Managing Director, Medius AG
Manuel leads regenold's Swiss operation. He is the senior contact for clients working through Swissmedic and for non-Swiss sponsors who need a Swiss establishment licence to place pharmaceutical products or medical devices on the market. The licence is held by Medius AG, regenold's Swiss legal entity, near Basel.
He is a scientist and regulatory leader with more than fifteen years of operating experience in healthcare and medical technology. He holds an MSc in Nanoscience from the University of Basel and a PhD from University College London, where his research on nanomechanical sensors for early-stage drug discovery was published in Nature Nanotechnology, Nature Materials, and other leading journals. He later complemented his scientific training with a CAS in Management of Biotech, Medtech and Pharma Ventures from EPFL.
After a research career, Manuel moved into industry. He spent seven years on scientific affairs, project leadership and senior research roles at global dental and oral health companies, then held the chief scientific officer position at a start-up sized skin health company. He joined regenold in 2022, leading preclinical strategy and development projects for the device and IVD team, before taking on the regenold Switzerland CEO role in 2023. He works closely with clients across pharmaceuticals, medical devices, and combination products, with particular depth in early-stage development, regulatory science, and Swiss market access.
Tell us about your product, your timeline, and where you are in the process.
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