How we work
Providing a strategic market access
20+ years experience with global pharma and biotech companies
Reducing every uncertainty on the way through expert management
Compliance & market access
Our strict procedures and due diligence ensure legal and regulatory compliance worldwide. Deep local expertise allows to navigate political landscapes and market access challenges.
Price protection
We actively safeguard your prices by entering early and utilizing US prices with Named Patient Programs. During later stages of registration and reimbursement, we collaboratively define optimal measures to protect your prices across all markets.
Financial security
We manage payments and currency fluctuations, guaranteeing on-time payments in a stable currency like USD or EUR. You retain full upside potential, while we focus on eliminating all financial risks and provide stable cash flows.
Crafting strategies to navigate emerging markets
We address every challenge in emerging markets with in-depth local insights, strong distribution networks, and tailored strategies for successful market entry.
Understanding local regulations and customs
Benefiting from our local managers’ deep connections, we gain unparalleled insights into the regulatory frameworks of each market where we operate.
We have a team proficient in the languages and cultural nuances of every market, ensuring optimal product commercialization.
Building strong local networks and supply chains
Our extensive network of KOLs, local partners, patient organizations and government bodies ensures streamlined processes and faster commercialization of orphan drugs.
Partnering with reliable wholesalers, has allowed us to built a distribution network that delivers essential medications to patients across diverse markets.
Tailoring activities to local market context
Recognizing that market access regulations vary widely in emerging markets, we employ different approaches as needed.
Therefore, we tailor every activity to the specific context of the market and drug, ensuring optimal commercialization strategies.
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.
Adopting a proactive regulatory compliance
Our approach ensures tailored responses to specific regulatory needs for each country and product. By staying attuned to local regulations, we swiftly adapt to changes and challenges in the evolving regulatory landscape.
Key pillars in our regulatory approach
01.
Appointing a designated compliance officer and committee.
02.
Providing effective training and education.
03.
Establishing an effective line of communication.
04.
Conducting internal audits and monitoring.
05.
Upholding standards through published disciplinary guidelines.
06.
Promptly addressing challenges as they occur.
Maximizing your revenue with efficient collaboration mode
Competitive and flexible pricing model
Our pricing model is designed to be flexible, aligning with product specific commercialization costs while avoiding upfront payments. We offer competitive margins, providing extensive services and personalized attention without requiring long-term contracts or licensing rights, allowing our clients to retain control and full upside potential.
Streamlined operations with minimal resources
We integrate with your team by handling administrative tasks and offering personalized support. This means you only need one contract to access over 30 markets, allowing your core business to thrive without dedicated alliance managers.
Rapid market access and revenue realization
Utilizing deep pathway expertise, we achieve launches as early as day 2 post-FDA approval. Our comprehensive global assessment before contracting includes a detailed launch timeline, guided by a team of 50+ medical doctors, 10 PhDs, and field experts.
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.