OUTSOURCING FUNDAMENTALS
Consistent, Reliable, High-Quality Components
Discover a premium line of components for vials, prefilled syringes, and cartridge systems developed and refined to provide best-in-class levels of quality, performance, and risk mitigation.
Annex 1 FAQs: Responding To The 2022 Revision
Viewing the Annex 1 revision as a natural extension of current habits, rather than a burden, allowed for a seamless transition. Since contamination control was already standard, the update simply validated existing excellence.
Selecting A CDMO: A Guide To Successful Collaboration
Join Dr. Srinivasan Shanmugam in this webinar to learn key strategies for selecting the right CDMO, reducing costs, accelerating timelines, and ensuring product success.
Annex 1 FAQs: Why Is A Good Supplier Partnership Pivotal To Meet Regulatory Expectations?
Struggling to keep pace with EU GMP Annex 1? The right supplier partnership brings critical regulatory insight your team may be missing. Learn how strategic collaboration closes compliance gaps and prepares you for future regulations.
Fostering CDMO Collaboration On Both Sides
Hear an industry expert share his perspective from both the pharmaceutical and CDMO sides of the table on why partnering with a collaborative CDMO can make a significant impact on a program’s success.
Managing Multiple Partners – And Materials – From Around The Globe
Two development and manufacturing outsourcing professionals – one based in Australia and one the east coast of the U.S. – begin our discussion on global outsourcing.
Start With An Integrated, Verified PFS System
Synchrony S1 PFS system delivers an integrated, verified solution designed to streamline submissions, support reliable supply, and reduce development risk.
Delivering Top Quality Fill Finish Manufacturing
Bringing an innovative parenteral drug product to market requires a fill finish manufacturing partner with the resources and solutions to deliver top quality products and the agility to meet your needs.
Annex 1 FAQs: How Is Behavior Changing As A Result Of EU GMP Annex 1?
EU GMP Annex 1 is driving meaningful changes in how teams behave inside cleanrooms. Understand what contamination awareness really means in practice and how to build a culture where speaking up is standard.
Minimizing Particulate Risk
While visible particles often draw immediate attention, visual inspection alone is insufficient, as subvisible particulate matter can pose equally significant risks to patient safety.
Annex 1 FAQs: How Are We Responding To Foster Trust With Customers?
When regulations evolve, your suppliers’ ability to adapt shapes your ability to deliver. Learn how stronger manufacturing, quality, and personnel standards combined with radical transparency make compliance an advantage.
Efficient, Single-Source PFS Supply
When component lead times don’t align, inventory piles up, cash gets tied up, and forecasts can quickly turn into waste or shortages. What if a single integrated PFS system could simplify it all?
Streamline Your Path To Clinical Fill
Drug-independent PFS testing is a required early step — but it can be time-consuming and resource-intensive. What if you could eliminate the effort without losing the data you need?
Annex 1 FAQs: How Do You Understand Risk Regarding Contamination Control?
True Annex 1 compliance requires a facility-wide contamination-control culture. Discover how rigorous risk awareness shapes behavior at every touchpoint across a manufacturing environment.
Annex 1 FAQs: What Was The Biggest Challenge With EU GMP Annex 1?
Translating EU GMP Annex 1 into consistent site-level practice is where most manufacturers struggle. Hear why the global-to-local execution gap remains the industry's biggest compliance challenge and what it takes to close it.
Planning For Scale-Up
From rapid early-stage production to scalable commercialization, discover the packaging and continuity challenges companies face as they prepare for launch.
Workforce Challenges Key To Outsourcing
Christine Feaster of QxP Consulting starts our discussion by focusing on a key to various realms of outsourcing: today’s workforce.
Protecting Your Drug Product
With patient lives depending on every dose, even minor vulnerabilities in containment or delivery systems can have serious consequences for product integrity and patient outcomes.
Visionary Thinkers And Problem Solvers: The Cambrex Team
Learn how the diverse backgrounds and fields of experience of the Cambrex team members help to provide you with the opportunity to change lives and seamlessly advance your molecule.
Start Packaging Development Early
To avoid costly delays later in the product lifecycle, it is essential to plan for key variables early and select container closure systems with confidence from the outset.
Annex 1 FAQs: How Are We Responding To Provide Confidence For Customers?
For procurement and quality teams evaluating packaging and delivery component suppliers, understanding how a partner responds to regulatory change matters as much as the quality of their products.
Redefining Prefillable Syringe System
See how our Synchrony S1 pre-fillable syringe system delivers an integrated, system-level solution designed for performance, quality, and scalability — with simplified submissions, synchronized supply, and compatibility across the drug delivery ecosystem.
Accountability For The Whole PFS System
When component suppliers only own their part, system-level performance becomes your responsibility. And if something fails, accountability disappears into the gaps.
Establishing A Container Closure System
As a trusted partner to both established and emerging drug developers, we support the safe, effective containment and delivery of life-saving and life-enhancing medicines.
Collaborating To Craft Efficient Processes
Learn why the right partner who takes the time to ensure processes work together in the most efficient way can help improve your program's success.