what we offer
Comprehensive commercialization solutions
We are proactive and transparent in providing optimal solutions across all commercialization phases
Guiding you to effective market entry
Maximizing market access for early patient treatment
Our focus is providing the most effective market access strategies for each country, covering all stages from Medical Affairs to final distribution. We leverage FDA / EMA approvals to ensure patients get early access to treatment through named patient programs (NPP).
A ‘’One-Stop Shop’’ model across 30+ countries
Simplify your operations with our single point of contact, streamlining due diligence, audits, language, currency, and adherence to European GDP and GMP standards.
Adapting to global changes by tailored regulatory solutions
Our capability includes delivering highly tailored responses to meet the unique regulatory requirements of each country and product. We promptly adapt to changes and mitigate risks in the evolving regulatory environment.
High level of dedication
Clear communication and innovative solutions
Our deep expertise ensures transparent interactions, providing creative and effective solutions tailored to your requirements.
Tailored forecast and timeline for your product
We will make an advanced analysis that includes forecasts of market size, along with a customized timeline for your product's specific needs.
Market access pathway timeline
Kick-off meeting
Introducing the project and finalizing the agreement.
in 0-3 MONTHS
Assessment
We evaluate market dynamics and competition to understand the landscape.
In 3-9 MONTHS
Identification of market access pathways
Determine access pathways based on known NPPs, EAPs, and local laws for rare disease products.
in 9-15 MONTHS
identification of KOLs and CoEs
We provide key opinion leaders and centers of excellence to support the project.
FDA APPROVAL
Launch
Achieving regulatory approval necessary for launching the product.
We can launch and access patients already here
In Biomedica countries.
in 0-6 months
Monitoring
To ensure product performance and patient safety.
Looking for a strategic guidance?
Reach out to our team for market assessment specific to your product and understand the financial impact you can achieve by partnering with us.