BlueDil International’s offering
Is it too early to enter the European market?
It’s never too early!
Timing is key.
BlueDil offers a flexible, customized approach to support you at every stage, from pre-launch to post-launch strategies, for your orphan therapy. Discover how we can support your product’s lifecycle for success in Europe!
Clinical success
toward submission
Hands-On Clinical Support: Close collaboration with Contract Research Organizations (CROs) to engage with clinical experts, potential investigators, and professional societies to strengthen your network and to facilitate the opening of clinical trial centers.
Patient Recruitment: Enhance clinical enrollment through targeted patient finding and support.
Early Access Programs (EAPs): Evaluate EAP opportunities in various countries to identify the best solution fitting your product characteristics and to ensure patients’ early access to therapy.
Strategic Participation: Represent your interests at key conferences and events.
Effective Troubleshooting: Address and promptly resolve challenges to keep your project on track.
Submission – access
and early work
Virtual Affiliates: Establish and manage your virtual affiliates across Europe to streamline your company’s presence in the region and to prepare for market entry.
Global Presence: Leverage on our expertise in public relations, corporate affairs to build a strong market presence and strengthen company reputation across Europe.
Reimbursement and Distribution: Lead efforts in reimbursement and access at country level and set up efficient product distribution channels.
First affiliate
and sales
Legal and Regulatory Guidance: Navigate legal and regulatory considerations for a cost-effective deployment strategy.
Affiliate Rollout: Plan and sequence the opening of affiliates to maximize investment and success.
Talent Acquisition: Identify and vetting candidates to ensure the right fit for your team.
Industry Integration: Join and engage with relevant industry organizations to strengthen your market position.
Outsourcing Solutions: leverage on outsourcing to select functions and optimize operations.
Partnering and supporting across all product lifecycle
BlueDil International (BDI) Fields of Expertise
Strategic Opportunity Evaluation
Strategic Opportunity Evaluation
Harness BDI’s deep understanding of rare diseases complex market through in-depth qualitative research, Key Opinion Leaders interviews and Advisory Boards. Our scientific expertise enables us to uncover strategic opportunities and deliver actionable insights.
Clinical studies: Accelerated Patient Recruitment and Early Access Programs (EAPs)
Clinical studies: Accelerated Patient Recruitment and Early Access Programs (EAPs)
Patient recruitment in clinical trials for orphan therapies might be challenging due to diseases low prevalence. BlueDil Int’l can support you in finding patients to enroll in clinical trials by establishing and nurturing the relationship with reference centers. Moreover, being time to access even more important for patients affected by a rare and often severe disease, BDI provides turnkey solutions to develop Early Access Programs.
Medical affairs
Medical affairs
BDI provides comprehensive support in Medical Affairs, including
mapping reference centers, building relationships with clinicians, and executing medical-scientific activities such as advisory boards, symposia, and educational initiatives.
Legal and Regulatory Affairs
Legal and Regulatory Affairs
BDI operates with the utmost respect for the current legal and regulatory frameworks at country and regional level, providing experienced professionals to guide you competently and transparently through the complexities of the various national health ecosystems.
Market Access, Price & Reimbursement
Market Access, Price & Reimbursement
Leverage BDI’s expertise to navigate the orphan drugs market. We craft tailored market access strategies that address the unique European, national, and regional requirements, ensuring optimal and compliant market entry.
Field Operations: Key Account Management (KAM) & Medical Scientific Liaison (MSL)
Field Operations: Key Account Management (KAM) & Medical Scientific Liaison (MSL)
At BDI, we deploy top-tier professionals such as MSLs and KAMs to drive medical, scientific, and commercial activities aligned with your product lifecycle, ensuring effective execution and impactful results.
Forecasting and Commercial Strategies
Forecasting and Commercial Strategies
BDI fine-tunes your commercial strategy by analyzing field insights and disease-specific factors. Our strategic forecasting and planning services help you navigate market dynamics and optimize your approach for maximum outcome.
Supply Chain: Logistics and Distribution
Supply Chain: Logistics and Distribution
BDI supports an efficient and reliable supply chain set-up, fully compliant with EU and national regulations.
Affiliate Setup and Optimization: Human Resources, Recruitment, and Management
Affiliate Setup and Optimization: Human Resources, Recruitment, and Management
BDI crafts personalized strategies for affiliate setup, operating as a Virtual Affiliate until you’re ready to establish your own offices. We provide comprehensive support throughout the entire process, from human resources and recruitment to management, ensuring a smooth transition and successful establishment.