Services

From Strategy to Commercialization - One Partner.

We unite strategic go-to-market advisory with a license-ready commercial platform to de-risk entry, accelerate patient access, and help you retain full control.

Financial Discipline & Resource Allocation

We ensure smart, value-driven use of capital, prioritizing high-impact activities and sequencing investments for maximum return.

Milestone-Driven Planning

We build clear, time-bound roadmaps linking science, market readiness, and access, each phase measured and aligned with investor and board expectations.

Early Revenue Generation

When eligible to Early Access Programs (EAP), we integrate them into your strategy to generate early revenue while preparing for launch.

Holistic & Cross-Functional Integration

We align regulatory, access, medical, supply-chain, and commercial workstreams so your teams move together, accelerating time-to-market and avoiding costly misalignment.

Geographical Sequencing & Interdependencies

We leverage regional clusters to define the smartest entry sequence based on regulation, pricing, and logistics, enabling faster approvals and coordinated growth.

Rare-Disease Mindset

We build strategies with empathy and precision for small patient populations and complex pathways

A fully integrated, investor-ready market-expansion plan that de-risks execution, optimizes capital use, and lays the groundwork for seamless transition into Mirava Bio’s Integrated Commercialization Platform or relevant expansion model.

We act as your regional virtual affiliate, combining all regulatory, quality, access, medical and commercial functions under a single contract.

Our entities are license-ready from day one:

ODD / MA Applicant & Holder

Validated Quality Management System (QMS)

WDA, MIA, GDP & GMP-certified infrastructure

Certified Personel: QP, RP, QA, QPPV coverage

Ethics & Compliance governance

Result:

Validated Quality Management System (QMS) Certified Personel: QP, RP, QA, QPPV coverage Ethics & Compliance governance Immediate operational readiness once approval is granted — no setup delays, no compliance gaps, and no heavy investment. Just a faster, fully compliant route to patients and early revenues.

Rare-Disease Marketing & Commercial Excellence

Patient Advocacy Support

Market Access & Payer Engagement

Supply Chain & Distribution

Medical Affairs & Scientific Engagement

Ethics & Compliance

Patient Identification & Diagnostics

Regulatory Affairs & Quality Assurance

We build cross-functional teams aligned to your launch needs, experts in Rare Diseases, ATMPs, and Cell & Gene Therapies.

You decide and control; we execute with precision.

Why Choose Mirava Bio?

Accelerated Market Entry

Mirava Bio’s integrated platform and seasoned team streamline entry into EMEE markets, reducing lead times and maximizing biotech valuation.

Maintain control

Partners retain authority over pricing, commercialization strategy, and critical decisions while leveraging Mirava Bio’s infrastructure

Operations Fully Digitalized

Mirava’s advanced digital platform ensures seamless management of the product lifecycle, enhancing efficiency and decision-making.

Rare Disease Drugs & ATMP Expertise

With deep experience of rare disease therapies, Mirava Bio offers tailored strategies to overcome unique market challenges.

Scalable, Flexible Partnership

Flexible services that grow with your needs, adapting to the demands of rare disease commercialization at every stage. The same partner, from day 1 to the LCM of your product(s)

Risk-Reducing Partnership

A fully flexible model that minimizes risk and upfront costs while optimizing efficiency — letting you retain full control and ownership.

Licensed Ready for Rare Disease ATMP Commercialisation

Mirava Bio is building a fully licensed commercial organization ready (WDA, GDP) to enable compliant ATMP and rare disease drug commercialization. Applications are underway, and we adapt our licensing portfolio to match product profiles, expanding as needed to ensure seamless market entry.

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