Applications | Production Automation | Combination Products & Drug Delivery Devices
Combination product manufacturing for FDA device and drug compliance
Combination products sit at the intersection of two regulatory worlds, and most CMOs are equipped for only one of them. Ascential has supported combination product programs through FDA Pre-Approval Inspection with no observations issued. Our deep experience includes:
- Class I, II, III Devices & Active Implantables (AIMDs)
- Combination Drug-Device
- Drug-Eluting Implantable Devices
- Controlled-Release Combination Products
- Spray Coating Drugs
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Solutions
Comprehensive manufacturing solutions for combination & drug delivery products
Combination products don’t get simpler when you scale them. Every additional unit is another opportunity for process drift, material variability, or documentation failure. Ascential’s integrated solutions and quality systems are built to withstand that pressure — at scale and through regulatory review.
Regulatory Readiness
Add cameras, metrology tools, and machine vision to your product. Our engineers consider your performance requirements and existing workflows to deliver intelligent, manufacturable solutions.
Pharmaceutical Integration
Handle and dispense active pharmaceutical ingredients (APIs) and excipients in controlled environments with defined processes. We maintain precise quality records, batch records, and process documentation to support regulatory review at any point from development to commercialization.
Design for Manufacturability (DfM)
Evaluate your combination product design against the demands of dual-compliance manufacturing before processes are locked. We identify drug-device interface risks, material compatibility concerns, and assembly complexity that could create compliance challenges or quality escapes at scale.
Assembly Process Validation
Assemble combination products in dedicated, contamination-controlled environments. Ascential ensures all validated process steps can be managed and optimized within a single manufacturing flow.
Pre-Approval & Routine Inspection
Prepare your product submission with a highly experienced team that brings real depth and breadth of direct PAI experience. Ascential has supported routine inspections with favorable outcomes, including inspections resulting in no FDA Form 483 observations and NAI classification.
High-Volume Scale-Up
Scale from pre-commercial batches to commercial production within a validated manufacturing environment. The Ascential Production System (APS) supports cellular production and continuous improvement to build processes that sustain quality at volume.
Capabilities
A proven quality infrastructure for combination product complexity
Most combination product programs underestimate the manufacturing complexity of satisfying both device and drug regulatory requirements simultaneously. Ascential doesn’t — because we’ve done it.
Harmonized FDA/ISO-Certified Manufacturing
Support both device and drug regulatory requirements within a single manufacturing program. Ascential’s dedicated facility for combination products is FDA-registered and has a quality system compliant with cGMP (21 CFR Parts 210 & 211) and ISO 13485. The site has a long history of inspection success in the CDER and CDRH space for combination products.
Thermoforming & Packaging Process Automation
For programs involving thermoformed components, trays, blisters, or sterile barrier packaging requirements, Ascential can help assess manufacturability, automation opportunities, process risks, and scale-up considerations. Our teams evaluate where custom automation, inspection, handling, assembly, or process optimization may improve throughput, consistency, and repeatability.
Electronic Batch Records & 21 CFR Part 11 Compliance
Capture production data electronically to support traceability, with systems and validation designed to support applicable 21 CFR Part 11 electronic records and signature requirements. Manufacturing steps, records, deviations, and disposition activities are documented through defined quality processes.
Contamination-Controlled Manufacturing Environment
Trusted, stable clean room environments focused on cross-contamination controls for drug-containing products. Product-specific defined contamination control programs, environmental monitoring, HVAC with cascading pressure flows, continuous monitoring, and defined gowning and PPE requirements, as well as applicable operator health and hygiene protocols. Our team is also experienced in cleaning validation.
Case Study
A decade of combination product partnership
A global life sciences company needed to scale manufacturing for a breakthrough combination drug-device oncology product — FDA Breakthrough-designated — requiring simultaneous device and pharmaceutical compliance while ramping to over one million units within a compressed launch window. Ascential designed and validated a multi-step clean room assembly process integrating pharmaceutical component dispensing, device assembly, inspection, and dual-barrier sterile packaging, with the Ascential Production System driving continuous improvement at volume.
The company now has a commercially validated, scalable combination drug-device program, with a proven quality and compliance record and a long-term manufacturing partner in place.
Why Choose Ascential?
Combination Product Manufacturing Expertise
Ascential understands the unique demands of combination product manufacturing, where repeatability, accuracy, quality, and speed are vital to capturing market share. We design systems that align with your technical requirements and production goals.
ROI-Driven Automation Approach
Automation only delivers value when applied strategically. Ascential identifies the highest-impact opportunities across your process, helping you reduce costs, improve yield, and scale efficiently, without overengineering or redesigning from the ground up.
Integrated Engineering
We work across disciplines and with your team to make process and design improvements with compliance in mind from the start. When you’re better prepared for FDA submissions and audits, you can accelerate market entry.
Full Product Lifecycle Support
Ascential stays engaged for the life of your product: through process design and development, scale-up, IQ/OQ support, technology transfers, and commercial support.
Frequently Asked Questions
Get answers to common questions about our combination and drug delivery device manufacturing capabilities.
Yes. Our Ham Lake, Minnesota facility is registered with the FDA under both CDER and CDRH (a requirement for manufacturers of combination drug-device products intended for commercial sale) and has been active since 2014. The facility is also ISO 13485-certified, PIC/S-compliant, and registered internationally, including in Japan, South Korea, and Brazil. See the full list of registrations on our quality and regulatory compliance page.
Our quality system is built to meet GMP requirements for regulatory submissions outside the U.S., including PIC/S, PMDA (Japan), ANVISA (Brazil), and MFDS (South Korea). We also have direct international Pre-Approval Inspection (PAI) experience with the MFDS for combination drug-device products. Full details on our quality and regulatory compliance page.
Our work spans from simple single-objective systems to complex fluorescent and confocal imaging configurations, including integration with sample- and fluidic-handling subsystems. We develop and qualify these systems for global medical development programs and manage their transition to manufacturing.
We engage early (ideally at the design or pre-commercial stage) to evaluate manufacturability, identify compliance risks, and build a manufacturing strategy that scales without surprises. Early-stage teams can inquire about how Ascential engages pre-commercial programs.
Yes. Ascential designs and delivers automation systems that handle thermoforming, including sterile barrier packaging such as trays and blisters, and helps manufacturers optimize existing forming workflows for improved throughput, yield, and repeatability. This pairs with our broader combination-product assembly and inspection capabilities.
Qualification spans several disciplines, including equipment qualification, test method qualification, cleaning qualification and validation, process qualification, and software qualification, and our team is highly knowledgeable across all of them.
We scope, budget, and document IQ/OQ/PQ support as a program deliverable and build GAMP 5 packages where required. We also apply a computer system validation approach that supports 21 CFR Part 11 for full data integrity across the manufacturing process.
Related Resources
Scale your combination product program with a clean PAI record
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