We deliver tailored manufacturing services for companies developing products that require clinical trials and small batch builds. With flexible small-batch manufacturing and specialized regulatory support for drug-led combination products, we help bring new life-saving medical innovations into market.
Our Expertise
Clinical & Small Batch Builds
Clinical Trial Manufacturing
The likelihood of clinical trial success hinges on choosing a trusted partner to design and develop reliable drug delivery devices. With a proven track record in clinical trial support, we offer flexible manufacturing services for combination products like autoinjectors, pens, pre-filled syringes, and inhalers.
We offer drug kitting and device manufacturing services for combination products for clinical trials and market introduction.
Over the last two decades, Accola has supported hundreds of combination products on their path to market.
Market Introduction
New medical devices and combination products need a reliable manufacturing partner for small batch runs as they gain adoption from customers and clinicians.
We have expertise in verifying and validating processes and products in small batch manufacturing to ensure device success for early users.
We offer scalable manufacturing services that grow alongside your product’s adoption in market.
Program Support
We understand the challenges associated with innovative combination products and provide expert regulatory guidance, including support for primary container documentation and relevant eCTD submission sections.
We support long-term manufacturing partnerships, ensuring seamless progress through the FDA approval process.
We provide regulatory guidance tailored to combination products, helping teams navigate complex submission requirements and agency expectations.
Locations
Global reach and flexible
manufacturing solutions for
projects of any size
Talk to an Expert
Accola combines engineering expertise, advanced manufacturing capabilities, and regulatory support from concept to commercialization to bring your ideas to life. Ready to turn your vision into reality? Talk to an expert today.