Leading consultancy for regulatory affairs, QA, pharmacovigilance & market access

How we work

As a leading regulatory affairs consultancy, we provide end-to end support from strategic oversight to hands-on execution. We offer transparent communication, scalable support, and cross-functional collaboration across regulatory affairs, quality assurance, pharmacovigilance, and market access. Explore how we work as your partner – efficiently, compliantly, and with true regional insight.

Selecting the right consultancy is critical to navigating regulatory complexity and accelerating success in the highly regulated life sciences landscape. Whether you’re launching a new pharmaceutical, biotech, or medical device product in the EU, UK, or Switzerland, the most effective consultancies combine deep functional expertise with local regulatory intelligence, cross-border coordination, and tailored service models that align with your internal capabilities.

Passion for the process

We take pride in being flexible. You can pick and choose services as you grow, covering all your development alternatives.

Specialist consulting

Arex specialist consultancy is a flexible, pay-as-you-go solution for companies that require short-term strategic advice or operational support within all of Arex specialist areas. We provide experts on an ad-hoc basis to support you in reaching your objectives.

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Project support

Arex project support is intended for larger, mid- to long term activities including one or several of Arex specialist areas. Together with you we define the scope and budget of the project and include all the necessary competencies for a favorable outcome.

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FTE insourcing

Arex FTE insourcing is a service that offers a high degree of integration into the clients’ organization and activities. We provide a dedicated expert for a certain period, allowing for a flexible solution that can be aligned from time to time in accordance with the business need.

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Scenic view of water and a cliff in Ang Thong, reflecting Arex's team composition. Extensive backgrounds in senior global roles and projects from small to medium-sized enterprises

Our experts:

  • 27% have a PhD degree
  • 16% have Health Authority experience
  • Experience from senior global positions
  •  Significant experience from small to medium-sized enterprise projects
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Close-up of small trees growing on a mountain in Zhangjiajie, representing Arex's expertise in pharmaceuticals, biologics, biotech, medical devices, IVDs, combination products, ATMPs, and herbal, food supplements, and FSMPs.

Our experience:

  • Pharmaceuticals
  • Biologics and biotech
  • Medical devices and IVDs
  • Combination products and ATMPs
  • Herbal/Food supplements/ FSMPs
Our services
our_clients_in_pharma

Our clients:

  • Global organisations
  • Small and medium enterprises
  • Specialty pharma
  • Startups
  • CMOs/CDMOs
  • Distributors
Our services

FAQ: Finding the best consultancy for Regulatory, QA, PV & Market Access Support

Can one consultancy cover regulatory affairs, PV, QA, and market access together?

Yes – Arex Advisor offers integrated services, creating better alignment across functions. This reduces friction, ensures consistent strategy from development through post-marketing, and simplifies vendor management for your team.

Why is quality assurance (QA) consulting critical for pharma companies?

QA consultants ensure your quality management systems (QMS) align with EU GMP standards. They can support audits, CAPA plans, risk management, validation, and supplier oversight – helping companies avoid compliance pitfalls that delay product launches or lead to recalls.

How do pharmacovigilance (PV) consultants add value beyond basic compliance?

Specialist PV consultancies not only ensure compliance with EU GVP Modules, MHRA expectations, and Swissmedic guidelines, but also help design efficient safety systems, handle signal detection, and act as your QPPV. This proactive approach reduces liability and builds trust with regulators.

What role does a consultancy play in market access strategy in Europe and the UK?

Expert consultancies help you navigate pricing and reimbursement pathways, prepare HTA submissions, and identify payer expectations early. With regional expertise, they align regulatory timelines with market access strategy to minimize time-to-market.

How does Arex Advisor integrate AI tools in their work?

At Arex Advisor, we have implemented AI tools to improve productivity and efficiency. Before implementation, the AI tools have undergone careful vendor qualification, to ensure they comply with our quality management system (QMS).

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.