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Healthcare professionals worldwide are faced with the challenge of treating patients who need a medicine that is not locally available to
them. The drug may not yet be launched in their country, been discontinued, or is simply in short supply. In these instances, physicians
and pharmacists need to source and dispense patient specific, difficult-to-obtain treatment, often on an urgent basis.
One-World has been supplying healthcare professionals these treatments for over 20 years. We understand the urgency and take this
into consideration as we promptly and securely facilitate delivery of these urgent medicines.
Clinical Trial Supply has been a driving force of One-World’s business since the company was founded in 2001. We offer efficiency, dependability,
and confidentiality to sponsors, CRO’s and institutions procuring pharmaceuticals for clinical trials.
Because of our extensive international experience, we have developed strong supplier and manufacturer relationships worldwide.
We can:
One-World works with U.S. manufacturers and distributors to provide investigational or unapproved drugs to providers so they can treat their patients for serious or life-threating diseases or conditions. Managed access terminology includes locally defined pre-approval access mechanisms such as “Compassionate Use”, “Expanded Access”, “Temporary Authorization (ATU), “Named Patient Supply” among others.
Logistics outsourcing for “high touch – high value” biologics has become a recommended practice for the storage and handling of critically sensitive products. Traditional logistics companies are not well versed and try to incorporate these services into their existing high-volume business models. One-World has been in the business of handling specialty pharmaceuticals for over 20 years, evolving with the industry, and always improving our processes.
Our clients include:
Medicine shortages can occur for many reasons:
Typically treating chronic or terminal conditions, specialty drug treatments are the fastest growing pharmaceutical sector in the world. Most
specialty drugs are first launched in the U.S. with registration in the E.U. to follow. Based on the patient population in international markets, the manufacturers may not seek to extend registration.
One-World steps in to fill the distribution gaps. We work with international healthcare entities to secure these products for their patients using
ethical regulatory pathways available for this purpose.
Orphan drugs are defined as “drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases and
disorders that affect fewer than 200,000 people in the U.S. or less than 5 per 10,000 individuals in the European Union.”
We provide orphan drug distribution outside the U.S. by:
Our fully licensed and trained staff works closely with the Atlanta office of the USDEA, the state of Georgia Drugs and Narcotics Agency, and the USDEA export office in Washington, DC. We provide CII-CV international shipping services and sales for manufacturers and facilities that do not have the proper licenses or expertise.
