Having successfully partnered in the launch of 15 significant orphan and niche drug products into the EU market over the last 3 years, Almac is the industry leader for Pharmaceutical Product Launch and Distribution.
The European marketplace presents a variety of challenges, from numerous official working languages to complex regulatory frameworks. With the knowledge and expertise of our professional Product Supply Managers, we can ensure your pharmaceutical product launch runs smoothly.
We have supported many of the industry’s recent first in class, innovative orphan drug launches in areas such as Cystic Fibrosis, Muscular Dystrophy, Hemolysis and Short Bowel Syndrome.
Our Dedicated Product Supply Team
Our dedicated product supply team are experts in navigating market requirements and supporting client partners to successfully launch their orphan / niche drug products. They have extensive practical experience of launching pharmaceutical products into the marketplace and manage a multidisciplinary project team in quality, packaging design, regulatory and distribution, ensuring milestones are met and that your market entry strategy is successful.
In our experience, it’s never too early to start to think about your pharmaceutical product launch. We take pride in our ability to support our clients with varying time frames, from as far as 24 months before submission of their MAA to those with shorter time frames, post submission.
Having successfully supported the pharmaceutical product launch of 15 high value niche and orphan drugs over the past three years, we can provide expert guidance on launch strategy and offer the following tailored solutions:
Named Patient Supply and Early Access Programs
Meeting Patient Needs
Named patient supply programs have many benefits for both the patient and your organisation. For those patients that have participated in your clinical trial and have benefited from treatment, this program can provide continued access to the drug product after the clinical trial. This type of supply can also facilitate market penetration by enabling physicians and patients in Europe to access drug products that have been approved by the EMA, but the pharmaceutical product launch has not occurred in the individual member states. While pre-launch access is permitted by EU legislation, Named Patient Programs are governed by the individual member states, which have their own regulations regarding access and specific requirements for supply. We have successfully developed, implemented and managed Named Patient Supply programs in over 30 markets. Our expert distribution and product supply teams can help alleviate some of the unknown logistical and regulatory pathways associated with your pharmaceutical product launch, allowing for a quicker supply process.
QP Declaration, Site of Release and Finished Product Market Release
Nominating a Qualified Person (QP) for the release of your drug product to market is a requirement when submitting your MAA. Our experienced QP’s can act as an extension to your team, putting in place relevant quality agreements between all manufacturing sites, and taking responsibility for product quality and market release, ensuring your qp declaration.
EU Import Testing and QP Release
Expert Guidance on EU Import Testing and QP Release for Over 40 Years
If your drug product is manufactured outside of the EU, it must be fully tested by a lab within the EU, to an approved EU specification. Medicinal products cannot be released for sale or supply until they have received certification by a Qualified Person (QP) and a batch must be fit for purpose and be processed and handled in accordance with Manufacturing Authorisation (MA).
With state-of-the-art analytical laboratories at the ready and employing over 250 analysts, we are able to provide EU import testing for bulk product. We test both small and large molecules and our dedicated microbiological analyst team can address all of your biological product-testing needs.
We hold a Manufacturers Import License as required by EU legislation and employ a dedicated team of five Qualified Persons (QPs) to monitor and certify the release of drug products to the marketplace.
Reduce Your Stock Holding and Minimize Costs
To minimise your stock holding and maximise it’s flexibility, we can assist you in developing regionalisation strategies (grouping markets into multi-language/country packs). By engaging our expert forethought and guidance on regional packs, we help to ensure that, where appropriate, smaller markets can be served without committing stock to orders that may never arise. Our late stage customisation and just-in-time processing of regionalised packs results in one pack being available for as many as 5 markets. Processing drug products just in time and tailoring your stock to the market provides increased flexibility, reduced stock holding, minimised costs and reduced lead-time to the end-user.
Order and Financial Management
Enabling a Shorter, More Flexible and Fully Integrated Drug Product Supply Chain
We receive direct orders 24/7 from registered pharmacists via a secure web based Product Order Portal (POP) or alternatively through a dedicated email, multilingual telephone or fax-based channels. This ensures a smooth, rapid delivery.
Utilising an integrated customer billing application, we can also offer client invoicing, monitoring and reporting of customer payments, debtor follow up and account management. To receive a demonstration of our comprehensive online ordering system, please get in touch.
Simplifying Your Supply Chain
Processing product orders received directly from hospitals and pharmacies via secure online portal, phone and fax, we distribute to the end-user and then invoice for payment. We can develop and qualify suitable packaging configurations (including cold chain and controlled ambient shipments) or utilise temperature-controlled vehicles, which are supported by our data recording and tracking systems.
Our dedicated logistics team work with our distribution partners to ensure your drug reaches the pharmacy in optimum condition within 24-48 hours of an order being received. To make the distribution process as simple as possible, we can also assist with the management of all necessary import/export documentation and customs clearance.