ACCESS SOLUTIONS
Market Withdrawls
Helping pharmaceutical companies continue to provide post-withdrawal access within a specific market.
HOW IT WORKS
Planning for a safe transition
For various commercial reasons, pharmaceutical companies may want to withdraw a medicine from a market, even when demand from physicians and patients remains. The decision to withdraw can be complicated by the potential adverse impact on patients and the company’s reputation. Depending on the product and the market, it may be possible to continue to provide post-withdrawal access to the market, and we can help.
OUR ACCESS SOLUTIONS
From Early-Access to Compassionate Use, we take a comprehensive approach to access solutions.
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Expanded Access Programs
US FDA regulated pathways that allow provision of investigational new drugs (INDs) to patients with serious diseases or conditions who have exhausted approved therapy and cannot participate in a clinical trial.
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Compassionate Use
The use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available.
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Post-trial Supply
A program to maintain supply of the medicine to patients until it becomes commercially available.
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Early Access Programs
Allow pre-approval access to medicines for certain patients
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Donation Programs
Programs for pharmaceutical companies that are seeking to donate their medicines in low- and middle-income countries where patients do not have the insurance or financial means to pay for them.
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Drug Shortages
A service that sets up the infrastructure to respond to supply chain disruptions that can cause drug shortages and mitigate the impact on patient access to their medicines.
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Market Withdrawals
Providing ways to access a market post-withdrawal where demand from physicians and patients remain, and we can help.
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Global Access
We have the ability to access all products for request internationally – finding access to products in unmet demand of markets of need. We do this through NPP (processed through import).
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Clinical Supply Gatekeeper
We can help you effectively manage inbound requests for comparators and reference listed drugs.