Tailor-made Product Launch Solutions
Balancing speed with precision, our flexible suite of offerings provides you with a reliable, effective, and expert approach to support the successful and timely introduction and launch of your new product and market penetration into new territories.
With over 55 years’ industry experience and supporting the launch of over 20 products annually, we understand the various challenges you face when preparing your new treatment for launch.
From the outset, and working at your pace, we will consult, plan and prepare for every possible scenario in order to agree the most suitable framework for your new product introduction, new SKU and ongoing global supply. This will ensure every eventuality is assessed and mitigated against and we can move forward to a smooth transition to launch.
Tailor-made Product Launch Solutions
We can provide expert guidance on launch strategy and offer the following tailored solutions:
- Product launch models designed to suit your timeframe and specific requirements including rapid launch and expedited product supply
- Full-service co-ordination
- Named Patient Supply and Early Access Programs
- Late-stage customisation
- Meeting Patient Needs
- We have successfully developed, implemented, and managed Named Patient Supply programs in over 30 markets.
- QP Declaration, Site of Release and Finished Product Market Release
- EU Import Testing and QP Release
- Expert Guidance on EU Import Testing and QP Release
- With state-of-the-art analytical laboratories at the ready and employing a dedicated team of 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 Qualified Persons (QPs) to monitor and certify the release of drug products to the marketplace.
- Regionalised Packaging – Reduce Your Stock Holding and Minimise Costs
- Order and Financial Management – 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.
- Integrated customer billing application
- End-User Distribution
Pre-Submission
QP Declaration & Site of Release
Packaging Design
Submission
Named Patient Supply
Country Groupings (Blue Box)
Artwork Origination
Shipment Validation
EU Import Testing
Product Tax Status
Approval, Launch & Ongoing Commercial Supply
Product Ordering, QP Release, Serilisation
Product Distribution to pharmacy, Product Invoicing
Our dedicated product supply teams 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, artwork & packaging design, regulatory logistics and ensuring key milestones are met.
We have supported many of the industry’s first in class, innovative orphan drug launches in areas such as Cystic Fibrosis, Muscular Dystrophy, Hemolysis and Short Bowel Syndrome. As an industry leader for Pharmaceutical Product Launch and Distribution Almac has successfully partnered in the launch of more than 20 significant orphan and niche drug products into the EU market over the last 3 years.
Our dedicated logistics team works with our trusted and reliable distribution partners to ensure your product reaches its final destination 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.
By integrating all of your pharmaceutical and distribution needs for your pharmaceutical product launch into a single supply team, you will minimise your effort and maximise your return.