Arex Advisor AG

Regulatory affairs consultancy for pharma, biotech and medical devices across the EU, Switzerland, UK and globally; clinical trial advice, submission documents, strategy, lifecycle management, labelling, medical-device regulatory compliance.

CMC consultancy for pharma, biotech and medtech; early-phase CMC strategy, IND/CTD and Module 3 support, formulation and manufacturing advice, technology transfer, analytical method validation, documentation management.

Quality assurance consultancy for pharma, biotech and medical-device companies; QMS setup, auditing, GMP/GDP compliance, QP/RP services, complaints handling, quality agreements, batch evaluation and inspection support.

Pharmacovigilance consultancy for the EU, UK and Switzerland; QPPV and deputy QPPV, PSMF setup, adverse-event case handling, literature screening, safety database services, training and local PV functions.

Market access consultancy for pharma, biotech and medtech in Europe, the UK and Switzerland; early access strategy, HTA and reimbursement submissions, payer value proposition, economic model adaptation, tender support.