Your Strategic Partner in Healthcare Solutions
We provide end-to-end support for the successful commercialization and lifecycle management of pharmaceutical products and medical devices.
From regulatory compliance to market access and sales force deployment, our integrated services are designed to accelerate your product’s journey from approval to patient.
Marketing Authorization Holder
Your trusted partner in Europe.
We act as your MAH in selected territories, ensuring full regulatory compliance and seamless coordination with health authorities.
Full responsibility for product lifecycle management
Oversight of pharmacovigilance, quality, and regulatory obligations
Transparent communication and reporting
Regulatory Affairs
Navigating Complexity with Confidence
In an increasingly regulated global environment, we offer comprehensive regulatory affairs services to ensure your products meet all local and international requirements.
End-to-end regulatory consulting for pharmaceuticals and medical devices
Preparation, submission, and maintenance of marketing authorization applications
Expertise in EU regulations
Local representation with competent authorities
Acting as Marketing Authorization Holder (MAH) upon request
Strategic guidance on regulatory pathways and lifecycle management
Pharmacovigilance
Global Safety Oversight, Local Expertise
We ensure patient safety through robust pharmacovigilance systems tailored to your needs.
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EU-QPPV services and local PV representatives across Europe
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Pre- and post-marketing pharmacovigilance support
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Signal detection and risk management (RMP, PSUR/PBRER)
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24/7 safety monitoring and case management
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Integration with global safety databases and reporting systems
Market Acces
Bringing Innovation to Patients Faster
We help you navigate the complex landscape of pricing, reimbursement, and health economics to ensure optimal market entry and sustained access.
Price and reimbursement strategy and negotiation
Health technology assessment support
Stakeholder engagement and value communication
Market research and forecasting for informed decision-making
Our team of experienced medical and scientific professionals provides the insights and support needed to position your product effectively.
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Scientific and medical writing
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Expert input for regulatory and promotional materials
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KOL engagement and advisory board management
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Clinical data interpretation and communication
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Management of medical information requests
Scientific Support & Expertise
Translating Science into Strategy
Sales Force & Commercial Activation
Dedicated Teams, Proven Results
We deploy specialized sales teams to promote your products in key therapeutic areas, ensuring strong market presence and customer engagement.
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Hospital-focused Sales Teams across multiple specialties
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Therapeutic expertise in Infectious Diseases, Cardiovascular disorders, Gastroenterology, Pain management, CNS and Anesthesiology
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Strategic Marketing and Targeted Communication
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Compliance with Promotional Law and Regulations
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Tender Monitoring and Follow-Up
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Customer Service and Order-to-Cash Management
