Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge if you are not familiar with country specific requirements. Read more about Understanding and delivering your EU Orphan Drug Launch
A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.
The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasing strategic role. There will be a need for greater agility and speed to market.
To maintain the proper temperature of vaccines, West Pediatrics relies on Bluetooth low energy (BLE) data loggers for accurate and reliable temperature monitoring.
Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, the US and Europe are also a lucrative target for drug crime.
For most pharmaceutical companies, a key challenge is the ability to create and maintain an innovative and competitive distribution channel strategy.
The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.
Marken’s global network combines highly-trained staff with strategically located, state-of-the-art depots to enhance transportation flexibility and provide logistics expertise. As the only patient centric supply chain 100% dedicated to pharmaceutical, life sciences, and clinical trial industries, Marken is the expert on clinical trial distribution services.
Together, the InTemp CX500 data logger, InTemp mobile app, and InTempConnect cloud-based data warehousing service offer a seamless temperature-monitoring solution for Good Distribution Practices in the pharmaceutical supply chain.
KoolTemp® Room Temperature Solutions are the industry’s most complete line of room temperature systems. Featuring multiple sizes and selective shipping time capacities designed for your room temperature shipment needs.
KoolTemp® GTS Carry Packs provide the thermal and physical protection needed for the short-term transport or storage of delicate therapies. Available in three sizes (S, M, L) and standard and advanced (PCM) versions, GTS Carry Packs provide up to 10 hours of high performance protection for refrigerated products.
The InTemp CX400 Series is a family of high-performance data loggers for monitoring temperatures in refrigerators, freezers, and other temperature-controlled environments. InTemp CX400 series loggers feature a large LCD display to keep tabs on current and daily min and max temperatures throughout the day.
Distributing clinical trial materials or collecting biological specimens can become complicated when a patient cannot easily access a hospital or clinic. To overcome this challenge, Marken developed Direct-to-Patient (DTP) services several years ago and is leading the industry with this service.
KoolTemp® STS (Seasonal Transport Systems) frozen solutions are a full line of qualified dry ice and suppressed temperature (non dry ice) shippers. Featuring multiple sizes and selective shipping time capacities designed for your frozen shipment needs.
KoolTemp Refrigerated Solutions are a complete line of tested and qualified small parcel-to-pallet size cold chain shippers for refrigerated applications. The shippers are tested and pre-qualified in ISTA-certified and cGMP labs and Pre-Qualified for 2°C To 8°C Protection.
As compared to IV route, ODT can provide a convenient oral route of administration for proteins, peptides and vaccines. Join experts from Catalent for an overview of the challenges and opportunities in using ODT technology as a patient-centric drug delivery tool and get updates on the new developments in ODT technology including delivery of peptides and vaccines.
With transformational changes in biologics, there are increasingly newer formats of new biologic drugs including bispecific antibodies, antibody drug conjugates and antibody-peptide fusion proteins.
The complex structure of Biologics, the nature of the interactions with their partners, require accurate modelling method to predict their physicochemical properties.
Recent US and EU serialization mandates have introduced the GS1 DataMatrix barcode symbology into a much wider role in the pharmaceutical supply chain. While linear barcodes have served as identifiers for SKU- and lot-specific information, the more compact GS1 DataMatrix is now being used as the designated carrier for the greater amounts of data needed to authenticate and track each bottle and carton of prescription drug product. As the role of the DataMatrix has expanded, so has the need to read it consistently and reliably throughout the supply chain.
