Marketing Authorisation Application support

Your partner for EU approval

Are you planning to expand into Europe? Let’s discuss how we can streamline your regulatory journey and ensure a successful market entry.

Why choose us for your EU MAA?

  • Global expertise, local execution – We specialise in helping non-EU pharma companies succeed in Europe.
  • Regulatory excellence – proven track record of MAA approvals across EMA, MHRA, and Swissmedic.
  • End-to-End Service – From submission strategy to MAH transfer, we handle the entire process
Speak to an expert

How we support your MAA in Europe

We provide comprehensive, hands-on support to ensure a successful MAA submission, approval, and transition into the European market.

Regulatory strategy & gap analysis

  • Assess regulatory options and pathways
  • Identify gaps between FDA, PMDA, NMPA, MFDS, MHRA approvals and EU requirements
  • Advise on study design, bridging strategies, and scientific advice

Full MAA submission management

  • Compile, review, and submit eCTD dossiers aligned with EMA and national agency standards
  • Manage regulatory interactions, deficiency responses, and authority meetings

CMC & GMP compliance support

  • Prepare for EU GMP inspections and secure QP batch certification
  • Support tech transfer, site changes, and variations

EU applicant services

  • Act as applicant until MA approval in the EU and manage post-approval commitments
  • Maintain full regulatory and pharmacovigilance compliance
  • Facilitate MAH transfer post-approval

Pharmacovigilance & risk management

  • Provide EU QPPV services and set up a compliant pharmacovigilance system
  • Establish and maintain the Pharmacovigilance System Master File (PSMF)
  • Monitor signal detection, periodic reporting, and risk minimisation activities

Market Access & pricing strategy

  • Develop HTA and payer engagement strategies for optimal pricing and reimbursement
  • Support early market access and managed entry agreements

Key challenges for non-EU pharma companies entering Europe

Our team has the local intelligence and global expertise to guide you through the strict European regulations. Having an experienced project manager to lead the way, supported by subject matter experts, is instrumental for managing the challenges in your marketing authorisation application process.

Understanding and adapting to European regulatory requirements

  • The European Medicines Agency (EMA) oversees centralised marketing authorisation, but national agencies (e.g., MHRA in the UK, Swissmedic in Switzerland) regulate other pathways.
  • EU regulatory expectations often differ from those in the US and APAC, requiring companies to adapt their clinical, CMC, and pharmacovigilance data accordingly.
  • Regulatory procedures vary, with centralised, decentralised (DCP), mutual recognition (MRP), and national procedures needing careful selection.

CMC and GMP compliance with EU standards

  • The EU has strict GMP requirements, often more detailed than those in other markets.
  • EU QP (Qualified Person) batch certification is mandatory, meaning manufacturers outside the EEA must work with an EU-based QP for batch release.
  • Site inspections by EU authorities (EMA, national agencies) may be required, potentially delaying approvals.

 

Pharmacovigilance and risk management compliance

  • The EU requires a local pharmacovigilance system, including an EU-based QPPV (Qualified Person for Pharmacovigilance) and a Pharmacovigilance System Master File (PSMF).
  • Post-marketing surveillance and risk management plans (RMPs) often need adaptation from existing global strategies.

Market Access and pricing strategy in Europe

  • European pricing is subject to strict national pricing and reimbursement regulations.
  • HTA (Health Technology Assessment) processes vary across countries and must be factored into the launch strategy.
Your contact person
Portrait of Erik Hedner Arex Advisor

Erik Hedner

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

Contact us

Linkedin

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.