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.
In 2021, we provided regulatory services on 98 dossiers (writing and review), related to 38 products.
We support clients all over the world: 53% in the Americas, 19% in the Asia-Pacific region, and 28% in EMEA.
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).
In 2021, we provided regulatory services on 98 dossiers (writing and review), related to 38 products.
We support clients all over the world: 53% in the Americas, 19% in the Asia-Pacific region, and 28% in EMEA.
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.
Technology transfers safeguard your supply and improve capacity and distribution. Drug developers often perceive technology transfer as a challenging process with complex logistics at the nexus of processes, equipment, and staff expertise. We have extensive experience in successfully conducting technology transfers and have developed processes and techniques to proactively mitigate risks and address issues. Our experience spans several technology transfer types, including:
Our global experts are dedicated to ensuring that process validation meets all regulatory and current good manufacturing practice (cGMP) guidelines. We offer speed and agility to keep your projects on track and preserve your product supply, with seamless execution for right-the-first-time delivery. Working with us, you’ll gain access to a robust system to manage the product lifecycle, including insight to all stage gates required for each phase. Customers also benefit from access to stability studies, analytical data, release testing, and other regulatory documentation.
A multitude of regulations impact the supply chain for pharmaceutical products. Our team is well-versed in complex global and regional regulatory guidelines and requirements for shipping, handling, and storage. We remove logistical burdens with GxP and Prescription Drug Manufacturing Act (PDMA)-compliant fulfillment and distribution services for all products. Let us help you mitigate regulatory-related delays and rework to get treatments to patients on time.
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:
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.