Accola
  • Our Expertise
        • Our Expertise

          • Design & Development

            We bring innovations to life with manufacturing in mind.
          • Clinical & Small Batch Builds

            Program success starts with choosing a trusted device partner.
          • Electromechanical

            We build electromechanical solutions to enable healthcare innovation
          • Human Factors & Design

            We design products that truly serve patients and users.
        • Our Expertise

          • Regulatory Services

            Expert guidance through every stage of development.
          • Contract Manufacturing

            Flexible manufacturing that scales with your product.
          • Global Manufacturing Network

            Scalable solutions for global device manufacturing.
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  • Our Expertise
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Our Expertise

Contract Manufacturing

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Flexible manufacturing that
scales with your product.

Accola offers flexible contract manufacturing services to meet changing production demands, reduce lead times, and support growth at scale. We support everything from small batch builds to full-scale commercial production for drug delivery systems, medical devices, and diagnostics.

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Injection Molding

We offer in-house cleanroom and white room injection molding services to produce components used in medical and drug delivery systems. Our team excels at designing parts that transition seamlessly to molding tools, ensuring manufacturability and reliability.

We manufacture complex, multi-material components with tight tolerances and high repeatability using fully electric thermoplastic systems and up to 64-cavity molds.

Welding and bonding options such as ultrasonic, RF, and solvent bonding are available for complex builds.

Drug Handling

Our facilities are capable of manufacturing drug-device combination products like auto-injectors, cartridges, and pre-filled syringes. Assembly and packaging take place in ISO Class 7 and 8 cleanrooms under an ISO 13485-certified quality system that meets FDA, cGMP, and international combination product regulations.

Our packaging equipment enables sterile sealing and tamper-evident features to support safe drug preparation and delivery.

We provide drug handling services for small batches and clinical trials, enabling the initial market release of new combination products.

Sterile Barrier Packaging

Sterile barrier packaging is performed using validated processes such as pouch sealing, tray sealing, kitting, and labeling. Formats are selected based on sterility needs and regulatory classification, with in-process controls and final inspection to ensure compliance.

Packaging workflows are documented to meet regulatory requirements and maintain product safety.

Barrier systems are chosen based on sterility needs to protect product integrity during clinical and commercial use.

Design Transfer

Design transfer is structured to support manufacturing, validation, and long-term scale-up. Cross-functional teams collaborate with product engineers early to align on tooling, automation, and compliance, following defined checkpoints and maintaining full documentation for traceability and regulatory readiness.

We develop documentation in parallel with the build process to support both regulatory submissions and manufacturing needs.

We design transfer plans to streamline validation and ensure a smooth transition into production.

Locations

Global reach and flexible
manufacturing solutions for
projects of any size

Global Manufacturing Facilities

Regulatory

Expert guidance
through every stage
of development

Our team supports clients with the regulatory planning, preparation, and interaction needed to bring products to market and maintain long-term compliance. Our support includes preparing documentation, managing regulatory communications, and supporting submission processes for medical devices and combination products.

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Regulatory Filings & Interactions

We support 510(k) submissions, CE Technical Files, FDA Q-submissions, and preparation for meetings related to IND and NDA pathways.

Medical Device Development

We help devices obtain regulatory approval faster by creating strong strategies that align development with appropriate regulatory pathways across global markets.

Combination Product Development

Our streamlined quality system and drug handling capabilities accelerate development for drug delivery devices and combination products.

We have the experience and the people to
make your project succeed.

We have the experience and the people to
make your project succeed.

View Our Expertise

Design & Development
Compliance & Regulatory Services
Clinical & Small Batch Builds
Electromechanical
Human Factors & Design
Global Device Manufacturing

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.

Talk To An Expert

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Our Expertise
  • Design & Development
  • Contract Manufacturing
  • Human Factors & Design
  • Electromechanical
  • Clinical & Small Batch Builds
  • Regulatory Services
  • Global Manufacturing Network
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  • About Accola
  • Our Team
  • Careers
Resources
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  • Contact Us
  • (305) 203-6037

5143 Cranes Point Court, Orlando, FL 32839 USA

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