Arex Advisor
Exhibiting Companies
Information
Regulatory excellence with a commercial edge
Arex Advisor offers strategic advice and operational support in Regulatory Affairs, CMC, Quality Assurance, Market Access and Pharmacovigilance. With a joint perspective of regulatory compliance and commercial competitiveness, we are committed to the process of bringing important medicines to the market.
Our Swedish and Swiss cross-functional teams navigate the complexities of regulatory, quality and safety compliance. You can rely on our experienced project managers and seasoned subject matter experts to manage compliance risks and identify opportunities.
Arex is employee owned and built on partnership – leading to long term relationships and a dedicated team. Our mission is to help leaders and companies realize projects and reach goals.
Offices in Sweden (Stockholm, Lund) and Switzerland (Basel).
SERVICE OVERVIEW
REGULATORY AFFAIRS
Strategic Regulatory Affairs
- Regulatory strategies and plans
- Authority interactions
- Due diligence and gap analysis
- PIPs & Orphan Product support
- MAAs, incl. JCA support
- Senior experts (Non-clinical, Clinical, PK/PD, CMC etc.)
- Early access program
- Regulatory Lead
Regulatory operations
- Regulatory strategies and plans
- Authority interactions
- Due diligence and gap analysis
- PIPs & Orphan Product support
- MAAs, incl. JCA support
- Senior experts (Non-clinical, Clinical, PK/PD, CMC etc.)
- Early access program
- Regulatory Lead
Product information & Labelling
- Development and maintenance of product information
- Labelling expertise and regulatory strategy
- Blue box requirement
- Translation management and local product information services
CHEMISTRY MANUFACTURING CONTROL (CMC)
Regulatory CMC
- CMC strategies and plans
- Formulation development and manufacturing advice
- Due diligence & gap analysis
- Technical advice from development to manufacturing
- CMC project management
- CMC documentation management and writing
Technology Transfer
- Analytical method and validation advice
- Technology transfer project management & support
QUALITY ASSURANCE
QA services
- Auditing
- Quality Management Systems (QMS)
- Product quality complaints
- Quality agreements
- QA training
- QA services for development companies
Good Manufacturing Practice (GMP)
- Acting Qualified Person (QP)
- Commercial production support and advice
- GMP responsibilities for MA holders
- Quality control and batch evaluation and release
- Technology transfer support and advice
Good Distribution Practice (GDP)
- Acting Responsible Person (RP), incl. 24/7 coverage
- Evaluation/structuring of distribution system
- WDA application management, incl. inspection support
PHARMACOVIGILANCE
MA application support
- Provision of QPPV during MA application procedure
- Pharmacovigilance System Master File (PSMF) services
- Safety Data Exchange Agreement (SDEA) reviewing and support
PV function
- Adverse event management & case reporting
- Scientific literature screening
- Set-up or review of PV system for local markets
- Local PV function, including medical information
- PV training services
MARKET ACCESS
Strategy development
- Market landscape review
- Early market access strategy and value messages
- HTA/reimbursement submission strategy
- JCA collaboration and project management
- Commercialisation strategy and plan
Reimbursement applications
- Reimbursement dossier development
- Economic model adaptations to local context
- Tender support
- Communications/negotiations with authorities