Pharma companies everywhere are transforming their supply chains through restructuring and outsourcing. They are also exploring new technologies to increase efficiency. In a COVID-19 world, planning for supply chain continuity has become even more critical.
We offer flexible solutions to balance the risk and cost of clinical supply chain management to ensure the highest likelihood of success. Our strategic sourcing solutions support central, local, and regional sourcing of ancillaries with a highly qualified and high-quality supply base.
From 2020-2023, we provided regulatory services on 477 dossiers (writing and review), related to 185 products.
We support clients all over the world: 53% in the Americas, 19% in the Asia-Pacific region, and 28% in EMEA, 3% in rest of the world.
Thermo Fisher Scientific was the leading CMO receiving dose contracts of Non-NME NDA approvals for therapeutic drugs from 2013-2022 (44 Non-NME NDA approvals for therapeutic drugs).
We have developed an iterative process, broken down into proactive and reactive steps, to balance the risk and cost of clinical supply chain management. Here's how it works.
Proactive
Reactive
Proactive
Reactive
Proactive
Reactive
The Patheon pharma services team is committed to delivering continuous improvement, clear communication, and regular status updates to all our customers. We have experienced no major service disruptions during the pandemic. To better support the move to virtual, we are accelerating direct-to-patient and site-to-patient programs, as well as digital enablement of core processes such as virtual audits and site visits.
Integrity, efficiency, and risk mitigation are the cornerstones of our approach to transportation, allowing us to deliver your shipments on time, in full, and at the required temperature.
Supported by our global network of quality-approved providers we deliver on product security and industry compliance while optimizing distribution and transportation processes. Our Good Distribution Practice (GDP)-compliant services span the entire product development lifecycle, from bulk active pharmaceutical ingredients and clinical trials materials to product commercialization samples and finished goods.
Flexible modes and service levels include:
We are passionate about our commitment to quality and service excellence, constantly working to streamline and improve processes using our corporate practical process improvement (PPI) methodology. Our client support is characterized by personalized service, 24/7 support, standard operating procedures (SOPs), client-specific work instructions, comprehensive quality systems and maintenance of industry-standard certifications:
With growing pipelines of cell and gene therapies and biosimilars, the importance of a temperature-controlled supply chain has never been greater. Maintaining cold chain product integrity across the entire supply chain demands end-to-end temperature management and rigorous processes that strictly conform to regulatory guidelines.
We rely on global best practices, including optimal approaches for packaging, storage, and transportation, including:
Learn more about our clinical cold and ultracold chain logistics services.
There are significant, non-negotiable requirements for working with pharmaceutical products and materials—everything from temperature management to protect product integrity, mandated licenses and certifications, systems and processes that conform to regulatory guidelines, and end-to-end security of the supply chain.
As your strategic partner, we have the experience and expertise to serve your warehousing and distribution needs with outstanding accuracy, security, and efficiency, while meeting all regulatory and other requirements.