Pre-Approval regulatory consulting for EU Pharma and Biotech
Pre-Approval solutions
We work with pharma and biotech companies from clinical trial stage through to MAA submission and MA approval. Our cross-functional team of compliance experts delivers guidance across Regulatory Affairs, CMC, Quality Assurance, Pharmacovigilance and Market Access — helping your science get business ready.
Speak the language of Marketing Approval
How Arex accelerates your path to approval
Build your MAA strategy for clarity, quality, and success. Our experienced team has a proven track record of preparing and managing Marketing Authorisation Applications across EU procedures — from strategy and pathway selection to CTD dossier preparation and agency interactions with EMA and national competent authorities.
Regulatory Affairs & CMC
With the right expertise in regulatory affairs and CMC, complex requirements become clear, manageable development pathways. Our consultants bring cross-functional experience across the full pre-approval scope — helping you build a strategy that is both scientifically sound and commercially viable, from early development through to submission.
Quality Assurance
Experienced quality assurance translate regulatory requirements into practical, efficient quality systems that support development rather than slow it down. Our expertise helps you establish the right QMS, processes, and documentation from the outset — reducing compliance risk, securing your assets and investments and with the objective of driving development forward.
Launch readiness expertise
Whether you are planning to market your product after approval, or to divest it, your strategy should include a market access perspective. Early alignment of commercial strategy with regulatory and clinical development, will help you optimise pricing outcomes and patient access.
Key services in early phase pharma
Our cross-functional team of experts offer strategic advice and operational excellence across regulatory affairs, quality assurance and pharmacovigilance. With a joint perspective of compliance and commercial competitiveness, we support your journey from development to approval.
Arex Advisor develops integrated regulatory strategies for EU development programmes, including target product profile (TPP) definition, regulatory risk mapping, and scientific advice preparation. Consultants establish the most efficient path to Marketing Authorisation for the specific product type, indication, and patient population.
Consultants identify and manage EU regulatory pathway options including standard centralised procedure, Orphan Drug Designation (EMA), PRIME designation, accelerated assessment, conditional Marketing Authorisation, and decentralised or mutual recognition procedures – with timeline planning and risk-benefit analysis for each option.
Arex Advisor provides day-to-day regulatory operational support including project and document management, eCTD publishing, translation services, and direct agency interaction management with EMA and national competent authorities.
Clinical trial regulatory support covers IMPD (Investigational Medicinal Product Dossier) writing, GXP compliance advice, IMP labelling design and regulatory review, and CTIS (Clinical Trials Information System) submission management under EU Clinical Trials Regulation (CTR) 536/2014.
Chemistry, Manufacturing and Controls consulting covers CMC development planning, formulation and analytical strategy, analytical method validation guidance, technology transfer support from development to GMP manufacturing, and Module 3 writing for IMPD and MAA submissions.
Market access consultants conduct EU landscape reviews, unmet need assessments, and market potential analyses to inform product development decisions, clinical programme design, and reimbursement positioning — enabling commercial strategy and regulatory planning to proceed in parallel from early development.
Arex Advisor supports pharma and biotech companies preparing for investment rounds, licensing deals, or M&A transactions by conducting regulatory due diligence, identifying and quantifying regulatory risks, assessing supply chain robustness, and maintaining a quality data room with audit-ready documentation for investor review.
Quality assurance support covers document management system setup, self-inspection programmes, and acting Qualified Person (QP) services.
More about quality assurance services
Arex Advisor conducts GMP, GLP, and GDP audits, develops audit programmes and manages quality agreements aligned with EU GMP, FDA, and ICH Q10 requirements for the supplier qualification section of the pharmaceutical quality system.
More about quality assurance and GMP services
Arex GXP training offers cover GMP, GLP, and GDP fundamentals as well as in-depth company specific training for quality assurance specialists, manufacturing teams and upper management, and manufacturing teams – designed for pharma and biotech organisations preparing for commercial manufacturing or as part of inspection readiness.
More about quality assurance and GMP services
Arex Advisor experts support development and implementation of pharmaceutical quality management systems for early development phases to post market and distribution. The QMS should be suitable and relevant for the company and compliant with applicable regulations. In early development a pragmatic and functioning QMS will be a great benefit to ensure due diligence readiness.
Your contact person
Delphine Guérin