Industry-leading transportation and logistics services
Helping you navigate supply chain challenges
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.
98 dossiers
In 2021, we provided regulatory services on 98 dossiers (writing and review), related to 38 products.
Global support
We support clients all over the world: 53% in the Americas, 19% in the Asia-Pacific region, and 28% in EMEA.
44 Non-NME NDA approvals
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).
98 dossiers
In 2021, we provided regulatory services on 98 dossiers (writing and review), related to 38 products.
Global support
We support clients all over the world: 53% in the Americas, 19% in the Asia-Pacific region, and 28% in EMEA.
44 Non-NME NDA approvals
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).
Supply chain risk management (SCRM) process: Identify, Quantify, Mitigate
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
- Sole sources, single sources, regulated, long lead-time items, quality, delivery issues
- Financial, EH&S, cyber, socioeconomic
- Impact of natural disasters
Reactive
- Track and monitor suppliers for events that could affect supply chain
Proactive
- Assess risks we can mitigate
- Prioritize actions to make the biggest impacts to risk reduction
- Determine which risks can be addressed
Reactive
- Follow standard event management playbook with clear roles and responsibilities and de-escalation process
Proactive
- Document mitigation levers
- Local, division, group, or enterprise-level management
- Collaborate to effectively manage
- Continuous improvement
Reactive
- Post-incident review process and follow-up actions
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.
Supply chain and speed to market solutions and capabilities
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:
- Pharma production between sites and scaling up production
- Product from your site to our sites
- Product from a different outsourcing partner to Patheon pharma services
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.
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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.
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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:
- Air: Next Flight Out (NFO), time specific same day, overnight, second day, third day, or deferred service using commercial and chartered services
- Ground: Same day, overnight, second day, third day, or deferred service using truckload (TL) and less than truckload (LTL) services
- Parcel: Time specific same day, overnight, second day, third day, or deferred service commercial and residential delivery
- Water: Full container load (FCL) and less than container load (LCL)
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:
- GDP Certified
- Customs-Trade Partnership Against Terrorism (C-TPAT) Certified
- International Air Transport Association (IATA) Accredited Cargo Agent
- Transportation Security Administration (TSA)-Certified Indirect Air Carrier
- US Department of Transportation (DOT) Registered Hazmat Carrier
- World Cargo Alliancec (WCA) First Member and Pharma Member
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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:
- Managing temperature-controlled shipments in multiple ways, from ambient and controlled room temperature (CRT) to refrigerated (2°C to 8°C), frozen (-20°C), dry ice (-80°C), and ultracold liquid nitrogen (LN2) cooling
- Handling transportation of all categories of hazardous materials, including radioactive substances in limited quantities
- Working directly with many of the leading manufacturers in temperature-controlled packaging, shipping, and cooling technologies to design a best-fit solution for each client
- Partnering with vendors to design unique storage or transport shippers whenever specialized packaging is required due to size, duration, destination, and other factors
- Innovations in cold chain management and distribution: Track and trace
- Commercial packaging for cell and gene therapies
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.
- Highly secure and fully climate-controlled distribution centers
- Customized fulfillment and distribution programs—no one-size fits-all
- Capacity and expertise to manage the challenges of high-risk, high-value products
- Industry leader for sample delivery, sending materials direct to practitioners and to pharmaceutical representatives
- Comprehensive sample compliance services
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