Andreas Bott, Head Of Clinical TrialsIn fact, It’s actually multiple, seemingly insurmountable challenges, convoluted into one global, inextricable knot. Because whatever the trial company perceives the challenge to be, like as not, the reality is way more complex than that. Even if the product you need is available on the market, it may not be available in the quantities you need. Or the right packaging. Or the lead times don’t match the trial dates. And neither does the shelf life. It may not be licensed in the country it’s going to or won’t be by the time of the trial.
And right in the middle of this tangle of cross-border regulations, snagged supply chains, and red tape stands the calming presence of the international pharma solutions provider, Komtur Pharmaceuticals.
This is their world, from the back streets of emerging countries to bright, cutting-edge city hospitals and every potholed road, blocked border, and document demand in between. And they have a simple mission: To expedite drug procurement processes through smart, integrated clinical trial management services, with the client and patient securely at the centre.
Through its integrated networks of subsidiaries and qualified suppliers around the world, Komtur ensures borderless sourcing, storage, and delivery services from anywhere to anywhere in the world while comprehensively resolving the challenges along the entire product lifecycle.
There are, of course, many competent logistics specialists in the field, but Komtur earns its corn by starting much further upstream.
“We have licences on the ground in every country and our personnel communicate efficiently with the local experts to identify the regulations and ensure strict adherence”
Their experts will work with the sponsor and cast an experienced eye over the trial forecasts to work out precisely what the trial needs and when. Then they overlay these needs over real world data – product availability, production schedules or required supply – and plan out the entire sourcing strategy from end to end, round every conceivable corner, and anticipating every document that will accompany the drug on its journey.
“Unforeseeable events always happen, but good planning reduces threats to project objectives,” says Andreas Bott, Komtur’s Head of Clinical Trial Supply. “Nevertheless, even if a client comes in at the last moment with an urgent request, Komtur is their best chance of meeting their objectives.”
Their procurement and distribution services streamline and simplify the entire gamut of clinical trial supply. The company constantly expands its services and capabilities, providing cold chain storage down to -80 degrees, clinical site distribution, and licences for narcotics, psychotropics, and veterinary products.
Integrated Procurement and Distribution Without Borders
Supplying pharmaceutical companies with required samples and batches, as well as batch collection during the early stages of research, the company then continues its support by sourcing comparators, creating distribution networks, offering temperature-specific storage and transport, and frictionless import and export. They come into their own mediating supply from authorisation holders and manufacturers, negotiating a custom-made production of certain products or supplying ancillaries.
The Way is Prepared Even Before You Know the Challenges
And whatever the challenge, they’re already ahead of the game, holding a wide variety of import/export licenses for clinical trial materials and controlled drugs. So when special licenses are required for a product in a specific region, Komtur helps guide its clients with support and advice around the documentation and registrations and provides customs brokering wherever possible.
Our all-embracing subsidiary network helps us source and distribute drugs in markets practically anywhere on the planet, which makes a crucial difference for our customers
Whether pharma products are licensed or unregistered, Komtur’s in-house custom clearance and regulatory specialists find (or innovate) the most effective ways to import and export medical and pharma resources on time in each region, eliminating hurdles and making the processes seamless and cost-effective.
“Komtur’s dedicated key account managers monitor all the moving parts of all projects, every step of the way, making our operations more agile and able to deal with potential delays. So deliveries happen exactly as they should, exactly on time,” says Andreas Bott.
Granular Planning Down to the Minutest Detail
Temperature loggers in each shipment enable Komtur to record data and ensure product integrity throughout the supply chain. The devices have plug-and-play support, enabling freight forwarders to generate analytical reports of the temperature in their systems. In the event of a temperature excursion, Komtur proactively communicates with the manufacturer to acquire stability data and FFU (Fit For Use statement) to confirm the shipment can still be delivered on schedule.
In the event of a recall, Komtur also has procedures in place to track each batch from supplier to end user and, where necessary, can replace recalled products to minimize delays. The company holds all relevant GxP licences and certifications and has established internal procedures to ensure strict adherence to regulatory compliance. Komtur also employs local and internationally-certified pharmacists and QA specialists in each subsidiary to ensure compliance with regional and international regulations.
Dependable Service Beyond the Trial
If a clinical trial ends before marketing authorization is granted, pharmaceutical companies are often required to continue supplying drugs to patients on a compassionate use basis. Komtur assists sponsors in setting up such programs and managing supply until such time as marketing authorization in the respective country are secured.
Once a client has received marketing authorization in a first territory, Komtur can help them supply patient needs in additional markets by setting up an early access program based on, for example, named patient imports.
Smarter Storage
To supply temperature-sensitive products, Komtur employs GDP-qualified temperature-controlled transport and depot services that seamlessly integrate with local clinical trial procedures and requirements for each product under distribution.
Komtur’s state-of-the-art warehouses include vaults specially designed for controlled drugs and, according to local regulations, are equipped and licensed to store and distribute narcotics and psychotropic substances. They guarantee product quality across a wide range of temperature requirements, offering all-encompassing temperature excursion management.
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Komtur’s dedicated key account managers monitor all the moving parts of all projects, every step of the way, making our operations more agile and able to deal with potential delays
The storage facilities offer a temperature range of 15 to 25°C for ambient products, 2 to 8°C for cooling products, -15 to –30°C for frozen supplies, and -75 to -85°C for ultra-deep frozen products. The warehouses are therefore regulated by temperature control alarms that notify facility managers when the storage approaches borderline temperatures.
A Customer-centric Approach
Thanks to trusted, longstanding relationships with certified suppliers and service providers, Komtur is uniquely placed to manage and optimize clinical trial operations effectively.
When customers are unable to source a drug in their own country, the company simply takes the problem in its stride, mobilizing its global network of subsidiaries to source available stock in other countries and get it across however many borders are necessary to reach the client in time.
A typical real-life example is Komtur offering a one-stop comprehensive service portfolio (including labelling and site distribution) to a client and supplying products across five countries–in various quantities–distributing products from a centralised warehouse within 24 hours of the request.
Where necessary, Komtur also helps clients set up emergency response programmes, expediting the entire process to ensure deliveries at very short notice by road, planes, or even helicopters.
So Who Are Komtur?
Headquartered in Freiburg, Germany, Komtur has 17 fullyowned subsidiaries across 16 countries on four continents, each with its own extensive network of dependable, qualified suppliers, giving their customers access to global markets from a single source. They became a global player by putting patients at the heart of their operations.
Starting as a small city pharmacy, they established a reputation as a dependable supplier for local clinical trials.
Then when the HIV/AIDS pandemic swept the world in the 1980s, the consequential clinical research offered an expansion opportunity which Komtur took with both hands. Since Freiburg, at that time, was the drug development centre of Europe, the trusted little pharmacy was perfectly positioned to take up the reins as the first-choice clinical trial supplier. By the time the trials concluded, the company had grown into a significant pharma brand.
Since then, it has developed into one of the world’s foremost integrated pharmaceutical procurement and distribution service providers.
