We provide pharmaceutical and biotech companies with a single-point solution for product awareness and named patient importation in challenging international markets.
Through exclusive distribution and quality agreements with pharmaceutical and biotech companies, EarlyHealth Group can help organizations reach patients before commercialization, bridging the access gap during the local regulatory approval process, or to maintain named-patient access support indefinitely when registration is not an option.
We provide steady, reliable named-patient supply into territories while ensuring the highest standards of Quality and Risk Management under strict, SDEA agreements. We offer Medical Information and Pharmacovigilance services, as well as therapy and disease awareness support. Our customers always have full control of the supply chain process of their products.
DISCOVER OUR EXPERTISE IN MANAGED ACCESS PROGRAMS
Regulatory Strategy
and Compliance
Assistance in navigating the complex regulatory requirements specific to each country for managed access programs, including securing necessary approvals and ensuring compliance with local laws and regulations.
Patient Identification
and Enrollment
Systems and support for identifying eligible patients for the program and facilitating their enrollment, including disease awareness campaigns, potentially improving diagnosis, extending the reach of the access programs and enhancing enrollment.
Drug Supply
and Distribution
Management of the logistics involved, including challenging importation processes, customs clearance, and supply and distribution of pharmaceuticals in remote areas require local presence and thorough understanding of the access dynamics.
Data Collection
and Reporting
Implementation of systems to collect and analyze post trial data, relevant for assessing drug efficacy and safety in real world setting. Evidence collected in this stage can support regulatory submissions and negotiations with health authorities. Outcomes communicated adequately will also increase innovative therapy awareness and improved future access for patients.
ADDITIONAL SUPPORT SERVICES
Pharmacovigilance : Ongoing monitoring of the safety of the drug with a robust system to report adverse events, analyze data, and implement risk management strategies.
Patient Support Programs : Development of programs to support patients post-registration, which may include educational resources, adherence programs, and ongoing health monitoring.
Real-World Evidence Generation : Collection and analysis of real-world data post-launch to support further regulatory filings and market positioning. This can include observational studies, patient registries, and other post-marketing surveillance data.
Renewal and Variation Management : Handling the submission of necessary documentation for renewals, variations, or extensions of the drug’s market approval.
By providing these services, companies support pharmaceutical industry clients through the entire lifecycle of a drug, from managed access to full market introduction and beyond, ensuring both compliance and effectiveness of the therapy provided to patients.
Send Us An Enquiry
To learn more about how we can improve your managed access programs experience or receive a quote, please feel free to get in touch.