We bridge the gap to bring innovative rare disease therapies to patients across Europe, the Middle East, and Eurasia (EMEE).
We are an integrated service platform providing end-to-end solutions to Biotechs from clinical trials to commercial stage, ensuring successful market entry and sustained growth in Europe, Middle East and Eurasia, while improving access and care for rare disease patients.
We offer you our fully integrated platform and local presence to ensure access to your ATMPs for rare disease patients in the EMEE region.
A UNIQUE INTEGRATED PLATFORM SERVICE FOR RARE DISEASE BIOTECHS
Pre-Marketing Authorization
- EMEE Go-To-Market and Launch sequence: We develop a tailored launch strategy, including target patient population analysis, competitive landscape assessment, and pricing & reimbursement strategies.
- Regulatory Affairs:
- Marketing Authorization Application (MAA) Preparation and Submission: We compile and submit high-quality MAA dossiers to regulatory authorities, ensuring compliance with all requirements.
- Orphan Drug Designation: We support applications for Orphan Drug Designation and other regulatory pathways to accelerate market access.
- Scientific Advice: We facilitate interactions with regulatory agencies to obtain scientific advice and optimize your development strategy.
- Market Access: We help you navigate pricing, reimbursement, and early access programs, including horizon scanning for upcoming changes in the healthcare landscape.
- Intellectual Property strategy: We protect your intellectual property through IP strategy and management
Post-Marketing Authorization
- Supply Chain for Advanced Therapeutic Medicinal Products: We handle the complex logistics of rare disease therapies, including temperature-controlled storage, specialized distribution networks, and import/export regulations.
- Distribution and inventory management: We ensure efficient distribution and inventory control, including track-and-trace systems for product safety.
- Licence management (GMP, GDP, WDA etc.): We secure necessary licenses and ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Wholesale Dealer Authorization (WDA), and other relevant regulations.
- Market Access:
- P&R Strategy: We develop and execute pricing and reimbursement strategies tailored to each market, including health technology assessments (HTA) and payer negotiations.
- Post-Authorization Studies: We support the design and execution of post-authorization studies to gather real-world evidence and demonstrate the value of your therapy.
- Medical Affairs:
- Drug Safety & Pharmacovigilance: We provide comprehensive pharmacovigilance services, including adverse event reporting, signal detection, and risk management planning.
- Center of Excellence Training & Qualification: We assist in the development and qualification of Centers of Excellence for your therapy, including training programs for healthcare professionals.
- Relation with Patient Advocacy Groups: We build and maintain relationships with patient advocacy groups to understand patient needs and incorporate their perspectives into your strategy.
- Medical Information: We provide accurate and timely medical information to healthcare professionals and patients through medical inquiries and educational materials.
- Diagnostics and Screening: We support the development and implementation of diagnostic tools and screening programs to identify patients eligible for your therapy.
- Publications and Medical Communication: We develop and disseminate scientific publications and medical communication materials to raise awareness of your therapy.
- Quality Assurance:
- Quality Management Systems: We implement and maintain robust Quality Management Systems (QMS) in accordance with international standards (e.g., ISO 9001). We develop and implement standardized processes for all aspects of your product lifecycle, from manufacturing to distribution.
- Audit: We conduct internal and external audits to ensure compliance with quality standards and regulatory requirements. We perform mock shipments to test logistics and ensure seamless product delivery, including temperature monitoring and documentation. Mock audits: We conduct mock audits to anticipate any regulatory inspections and ensure compliance.
- Commercial:
- Sales Force sizing and effectiveness: We determine the optimal sales force size and structure considering factors such as patient population, diagnostic capabilities, level of expertises of the helathcare professional, market access, and competitive landscape.
- Launch readiness and execution: We develop and execute comprehensive launch plans, including pre-launch activities, market activation, and post-launch monitoring.
- Commercial Excellence: We drive continuous improvement and best practices in commercial operations, including sales training, performance management, and customer relationship management (CRM).
- Tender Management: We manage tender processes and submissions to secure public contracts, including pricing strategies and bid preparation. (If applicable)
- Commercial Analytics and Insight: We provide data-driven insights to inform commercial strategy and decision-making, including market analysis, sales forecasting, and performance tracking.