Access to excellence

For global teams

Welcome to a team of experts, selected for their specific knowledge, management skills, and vast experience in consulting.

A forked road in Zurich with a large glass-fronted building at the center, symbolizing the clear and guided paths Arex Advisors provides in regulatory affairs.

Passion for the process

Your valuable journeys are safe with us

We complete your global regulatory affairs team, securing development, as well as implementation, of your regulatory strategy. With Arex you have a full suite of regulatory expertise at your fingertips. Our committed experts lead the way with proven methods for efficiency and compliance. Throughout your journey, we manage risks and identify opportunities.

Relax, we’ve got you.

Crucial regulatory roles

Depending on your needs, we support with short- and long-term projects, integrating into the your regulatory affairs team. On fixed rate projects, we guarantee a set number of full time equivalents (FTEs). We also offer project based support and specialist consulting.

We provide the right expert at the right time:

ROLES

  • Regulatory Project Manager

  • Global Regulatory Lead

  • Clinical Regulatory Expert

  • Regulatory CMC Expert

  • Labelling Specialist

SENIORITY

  • Senior Expert 
    +10 years of experience

  • Expert
    +5 years of experience

  • Senior Consultant
    2-5 years of experience

  • Consultant
    Up to 2 years of experience

Product experience

Our team has experience from working with different types of products, in a range of global regulatory functions, at all stages of the product lifecycle.

Pharmaceuticals

Biologics & biotech

Medical device & IVDs

Combination products & ATMPs

Herbals/Food supplements/FSMPs

Global services and synergies

Leveraging the combined expertise of the Arex team is one of the strongest benefits for you. Our experts are used to navigating the complex environments of regulatory affairs and clinical research. This experience generates an understanding of timing, concurrence, and synergies between crucial specialist areas. Every individual consultant is backed by a powerhouse of knowledge.

Strategic advice

  • Regulatory strategies and plans
  • Scientific advise support
  • Clinical trials advice
  • Due diligence and gap analysis
  • Medical writing

Regulatory operations

  • Lifecycle management
  • Regulatory project management
  • Regulatory documentation management
  • Product information services

Chemistry, Manufacturing, Control (CMC)

  • CMC documentation management
  • CMC project management
  • Formulation development and manufacturing advice

Technology transfer

  • Analytical method and validation advice
  • Technology transfer support
Experience from regulatory procedures

Our experienced team knows how to navigate in the complex environment of global regulatory affairs. With knowledge of the global regulatory landscape and hands-on experience from processes, we help you succeed.

EU

  • Centralised procedure
  • Decentralised procedure
  • Mutual recognition procedure
  • Variations (1.A, 1.B, 2), line extensions
  • Renewal / Sunset clause
  • Orphan Drug Designation
  • Paediatric Investigation Procedure
  • Scientific / regulatory advice

US

  • NDA
  • BLA
  • Variations (AR, CBE-30, PAS)
  • Annual reports
  • Orphan Drug Designation
  • Paediatric Exclusivity
  • Type A, B, C
Your contact person

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.