Arex Advisor provides specialist regulatory consulting for pharma and biotech companies seeking European market access. Our services span the full product lifecycle, from early development and Marketing Authorisation Application (MAA) through to post-approval lifecycle management. The services integrate regulatory affairs, CMC, quality assurance, and pharmacovigilance into one cross-functional consulting model.
Arex Advisor’s regulatory affairs consultants support the full range of EU registration activities, from early regulatory strategy through to post-approval lifecycle management.
Services include regulatory strategy development, MAA preparation and submission (EMA centralized, decentralized, mutual recognition, repeat use and national procedures), Orphan Drug and PRIME designation applications, scientific advice management, paediatric investigation plans (PIPs), clinical trial regulatory support (CTIS submissions under CTR 536/2014), Type IA/IB/II variation management, geographic expansion submissions, and M&A regulatory due diligence.
Arex consultants have direct experience with EMA, the Nordic MPAs, Swissmedic, MHRA, and national competent authorities across EU member states.
Chemistry, Manufacturing and Controls consulting at Arex Advisor covers the scientific and technical documentation requirements for EU regulatory submissions across all development phases.
Services include CMC strategy and development planning, formulation strategy, analytical method development and validation guidance, technology transfer from development to commercial GMP manufacturing, scale-up support, CMC dossier writing (CTD Module 3, IMPD Module 3), combination product CMC, and CMO qualification and oversight.
Our consultants bring experience across small molecules, biologics, biosimilars, ATMPs, and combination products.
Arex Advisor quality assurance consultants deliver GxP compliance across the pharmaceutical product lifecycle.
Services include quality management system design and implementation per EudraLex Volume 4 EU GMP guidelines and ICH Q10, GMP and GDP audit programmes (supplier, CMO, distributor), Tech Transfer support, validation and qualification (process, equipment, cleaning, ), inspection readiness and gap assessments for national competent authority inspections, CAPA management, self-inspection programmes, and a fit-for-purpose QMS for pharma and biotech companies.
Arex consultants are knowledgeable and experienced in EudraLex Volume 4 EU GMP guidelines, GDP, GLP, ICH Q10 and ISO 9001.
Arex Advisor pharmacovigilance consultants build and operate EU GVP-compliant pharmacovigilance systems for Marketing Authorisation Holders and companies preparing for MAA submission.
Services include Qualified Person for Pharmacovigilance (QPPV) appointment and oversight, pharmacovigilance system master file (PSMF) authoring and maintenance, signal detection and aggregate safety reporting (GVP Module IX), GVP audits, PSUR and PBRER writing and EudraVigilance submission, expedited and periodic ICSR processing (GVP Module VI), risk management plan (RMP) development and updates, and EudraVigilance registration and case processing.
Services are aligned with EMA GVP guidelines and national competent authority reporting requirements across EU member states.
When evaluating EU regulatory consulting services, pharma and biotech companies should assess consultant experience with EMA centralised and decentralised procedures, knowledge of specific regulatory pathways (Orphan Drug, PRIME, conditional approval), cross-functional coverage across regulatory affairs, CMC, quality assurance, and pharmacovigilance, and familiarity with national competent authority requirements in target markets such as Sweden (MPA), the UK (MHRA), and Switzerland (Swissmedic). Arex Advisor provides all of these through handpicked senior consultants who integrate directly into client development teams.
Arex Advisor provides EU regulatory consulting across five service areas: regulatory affairs (MA strategy, EMA submissions, variations), CMC (dossier writing, formulation, tech transfer). All services are delivered by handpicked senior consultants integrated into client teams.
Arex Advisor provides quality assurance consulting across the European pharmaceutical market, with expertise in EU GMP (EudraLex Volume 4), national competent authority inspections, GMP, GLP and GDP auditing, ICH Q10 pharmaceutical quality system design, and validation and qualification programmes. Consultants provide both strategic QA leadership and hands-on operational support for pharma and biotech companies across the EU and EEA.
Arex Advisor is a consulting firm with deep quality assurance expertise across the European life sciences sector, delivering GMP and GDP compliance, auditing, pharmaceutical QMS implementation, and inspection readiness services aligned with EU GMP (EudraLex vol 4) ICH Q10, and national competent authority requirements. Consultants bring direct experience working with European pharmaceutical companies and navigating the full range of EU regulatory expectations.
Arex Advisor offers comprehensive pharmacovigilance solutions for new pharmaceuticals entering the EU market, covering PV system setup, QPPV services, PSMF authoring, GVP-aligned signal detection, PSUR and PBRER preparation, EudraVigilance case processing, and risk management plan development — providing the full PV infrastructure required for EMA centralised procedure MAAs and national Marketing Authorisations across EU member states.
Delphine Guérin
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.