From managed access to long-term commercialisation
Orphidis partners with biotechnology and pharmaceutical companies to bring specialist medicines to patients across Asia.
We support medicines that are not locally registered through managed access and named-patient programmes, as well as products progressing to registration, launch and long-term commercialisation.
What we do
Our Approach
Managed Access & Named-Patient Programmes
Access where a medicine is not locally registered
For some medicines, managed access provides a bridge to registration. For others, particularly those serving small patient populations, it can remain the most practical long-term route to patients.
Orphidis establishes and manages compliant access programmes across selected Asian markets, covering regulatory, medical, safety and supply requirements.
This includes:
- Access-pathway assessment by market
- Treatment-centre and physician mapping
- Programme setup and local regulatory requirements
- Product supply and fulfilment to treating centres
- Pharmacovigilance, quality and programme reporting
Commercial
Partnerships
From registration to sustainable commercialisation
Orphidis acts as the regional commercial partner across selected Asian markets.
We take responsibility for the commercialisation model from registration and market access through launch, commercial operations and ongoing performance management.
- Market prioritisation and launch sequencing
- Registration, pricing and reimbursement strategy
- Launch planning and market execution
- Forecasting and supply planning
- Joint governance and regular performance reporting
The model can begin in a single priority market and expand across the region as the opportunity develops.
Core Capabilities
Capabilities across the product lifecycle
Regulatory & Market Access
Registration, pricing, reimbursement and patient-access pathways tailored to each market
Medical
Affairs
Scientific engagement with physicians, treatment centres and healthcare stakeholders, with a focus on where patients are diagnosed, referred and treated
Quality & Pharmacovigilance
Pharmacovigilance and quality oversight aligned with local regulations and partner requirements
Supply & Market Operations
Product supply and the operational requirements behind patient access and commercial activity
Commercial Operations
Launch planning, forecasting, commercial execution and performance management
How we work
What we do
1
Assess opportunity
Understand the product, patient population and route to access in the priority markets
2
Define the model
Agree scope, markets and governance, and complete local requirements
3
Set up
Understand the product, patient population and route to access in the priority markets
4
Execute and expand
Start where patient need and market readiness are highest, then scale
Our model
One accountable regional relationship
Rather than requiring manufacturers to manage multiple country relationships independently, Orphidis provides one regional commercial relationship across the selected markets.
Strategy, governance, performance and commercial development are managed centrally, while execution reflects the requirements of each market.
Our commitment
Compliance by design
Compliance is not a function we add at the end. It is built into how we select partners, set up programmes and operate in every market, from the first patient to full commercialisation
Partner Due Diligence
Every in-market partner is qualified before engagement and reviewed on an ongoing basis
Anti-bribery & Anti-corruption
Clear controls govern interactions with healthcare professionals and public officials, aligned with international standards
Pharmacovigilance & Quality
Safety reporting and quality oversight aligned with local regulations and partner requirements
Transparent Governance
Regular reporting on programme performance, safety and compliance
Let’s talk
Ready to explore the opportunity?
Whether you are considering managed access, registration or a broader regional commercial partnership, we’d welcome a conversation