A working reference for procurement leads, programme directors, and government stakeholders — the frameworks, primary research, and language you need to make confident decisions.
Continuous manufacturing went from a research-stage idea to a fully credentialed regulatory pathway in less than a decade. These are the milestones that defined the environment every programme operates in today.
Whether you're scoping a feasibility study or preparing a regulatory submission, these are the reference points your team will encounter.
A live, referenceable framework — not a news feed.The standards and FDA programmes that define how a continuous manufacturing programme is designed, submitted, and approved.
Foundational publications underpinning Bridge Health's process development expertise — and useful reference points for any team building a continuous manufacturing capability.
Independent reports we use to size opportunities and understand where the market and policy environment are heading.
A reference for anyone new to continuous manufacturing — the language used across process development, regulation, and project delivery.
12 termsA production process where raw materials are continuously fed in and finished product continuously comes out. Reduces lead times from months to days.
The traditional pharmaceutical production method. Each stage is completed separately before the next begins. Slow, wasteful, and vulnerable to supply disruption.
The international regulatory standard for continuous manufacturing, adopted by FDA and EMA in 2023. The framework every continuous manufacturing program must align to.
The FDA's program for building regulatory infrastructure around advanced manufacturing technologies. Designated end-to-end continuous manufacturing as its first priority.
A formal FDA designation that gives continuous manufacturing adopters prioritized engagement and expedited review. First designation granted April 2025.
GMP is the regulatory standard governing how pharmaceutical products must be manufactured. cGMP (current Good Manufacturing Practice) is the version enforced by the FDA, reflecting the latest expectations for manufacturing quality and control. Every commercial continuous manufacturing facility must be cGMP-compliant.
The section of a drug regulatory submission covering how your product is made, tested, and controlled. One of the most critical sections for continuous manufacturing programs.
Real-time monitoring tools that measure and control a continuous process as it runs. Enables real-time quality assurance rather than end-of-batch testing. Critical for continuous manufacturing regulatory submissions.
The structured process of demonstrating that your facility and equipment perform as intended and meet regulatory requirements. The final gate before commercial operation.
Installation Qualification, Operational Qualification, Performance Qualification. The three stages of equipment validation required before a GMP facility can operate commercially. Each stage builds on the last.
The biologically active component of a drug — the part that produces the therapeutic effect. API manufacturers are among the primary beneficiaries of continuous manufacturing transitions.
A country's ability to produce and control access to its own essential medicines without dependence on foreign supply chains. The policy driver behind most government manufacturing programs.
If you'd like to discuss how the current regulatory environment applies to your specific situation — pharmaceutical manufacturer or government — we're happy to talk.
