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Combination Products

Mastering the Interaction of Drugs, Biologics and Devices.

Recognized as one of the leading service firms for combination products, Kymanox® has guided the development and approval of 100+ products across all major therapeutic areas and delivery systems, bringing safer, more effective treatments to patients faster.

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CMC Support
Product & Device Development
MS&T
Clinical Affairs
Human Factors Engineering
Regulatory Affairs
Strategic Support
Program & Project Management

Chemistry Manufacturing and Controls (CMC)/Pharma Science

By embedding CMC strategy into device selection and program planning, we help clients de-risk development, avoid late-stage failures, and accelerate readiness for pivotal trials and global submissions.

FORMULATION DEVELOPMENT

Comprehensive support from early prototypes through commercial-ready formulations, ensuring drug compatibility with device components and optimal delivery characteristics.

DRUG–DEVICE COMPATIBILITY TESTING

Robust in vitro, extractables/leachables, and stability testing to evaluate chemical and physical interactions between the drug formulation and device materials, ensuring safety and efficacy.

CDMO/CMO VENDOR SELECTION and MANAGEMENT

Strategic partner identification, qualification, and oversight using risk-based approaches to ensure aligned expertise, manufacturing capabilities, and a strong compliance culture.

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Product and Device Development

We guide clients through the end-to-end development of drug–device combination products, ensuring drug formulation, device design, and regulatory strategy are fully aligned. From feasibility to design transfer, we reduce risk by integrating CMC, device engineering, human factors, and regulatory expertise into a unified development plan.

  • Choose
  • eXECUTE
  • SCALE
  • SUSTAIN

Needs Assessment & Device Selection

  • Comprehensive landscape and needs assessments to inform strategic decisions
  • Device feasibility and characterization testing
  • Vendor evaluation and platform performance analysis

Design Controls & Risk Management

  • Full support for FDA 21 CFR 820.30 and ISO 13485 design controls
  • Risk Management File (RMF) gap assessments and ISO 14971 remediation
  • Design verification planning and execution in our 2,000 sq. ft. design lab

Design Transfer & Manufacturing Integration

  • Phase-appropriate design transfer (clinical vs commercial scale)
  • Process development, qualification, and ongoing verification
  • Integration with downstream manufacturing and CMO/CDMO coordination

Commercialization & Lifecycle Management

  • Post-market surveillance, change control, and design change management
  • Support for design controls and risk management activities
  • Lifecycle strategies to maintain performance and regulatory compliance
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Manufacturing, Science, And, Technology (MSAT)

Optimize scalability and compliance for combination products with expert MSAT support. Kymanox utilizes deep manufacturing knowledge to ensure reliable device builds, streamlined technology transfer, and commercial-ready production. We support clients in reducing risk and accelerating timelines from development through launch.

  • End-to-end manufacturing process support for robust, reproducible results.
  • Process development and validation to meet global regulatory standards and quality requirements.
  • Clinical-phase device builds delivered with full GMP compliance for early and late-stage studies.
  • Technology transfer management and vendor qualification to support seamless scale-up and supply chain integration.
  • Sterilization compatibility services ensuring safety, efficacy, and regulatory alignment for commercial production.

From first prototype to reliable market supply, Kymanox MS&T keeps your program on track for quality-driven, compliant product delivery.

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Clinical Affairs

We connect clinical strategy with combination product development, ensuring that drug, device, and regulatory requirements align throughout clinical studies. Our experts help de-risk trials by integrating pharmacokinetics, usability, and regulatory expectations into study design and execution.

Clinical Study Planning & Interface Support:

Align study objectives with combination product requirements and regulatory expectations.

PK Modeling & Bridging Strategy:

Support for bridging studies (e.g., vial-to-Prefilled Syringe/Autoinjector (PFS/AI)) and Pharmacokinetic (PK) modeling for new delivery systems.

CRO & Vendor Selection

Identify and manage partners to support device-specific clinical studies.

Regulatory Documentation

Contributions to Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs) to support submissions.

Cross-Functional Integration

Coordination across CMC, device engineering, and human factors to ensure clinical trials generate data relevant to all regulatory pathways.

WHY THIS MATTERS

Combination product clinical programs require unique data sets, not just drug safety and efficacy, but also device usability, reliability, and performance in real-world use. Misalignment between clinical study design and regulatory expectations can result in gaps that delay approval or require costly follow-up studies. By integrating PK, device usability, and regulatory requirements, we ensure clinical studies generate the right data the first time.

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Human Factors Engineering

Our team includes former FDA reviewers from both CDER and CDRH, bringing deep insight into what regulators expect and how to design compliant, patient-focused human factors programs.

  • Human Factors Strategy & Regulatory Guidance

    Global strategy development, gap assessments, and submission readiness for FDA and international submissions. We align your program with regulatory expectations while keeping patients at the center of your design.

  • Human Factors Studies

    Formative and validation studies, actual use studies, and threshold analyses. We ensure the right methodology, participants, and metrics to generate results that matter for both patients and regulators.

  • Instructional System Design

    IFUs, training materials, and instructional videos developed with patient usability in mind. We test materials with real users before launch to reduce use errors and improve outcomes.

  • Risk Management

    Use FMEA, task analysis, and use-related risk assessment to identify critical errors before they impact patients. We integrate findings into your overall risk management strategy to support safe, effective products.

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Regulatory Affairs

Navigating regulatory pathways for combination products requires specialized expertise in Primary Mode of Action (PMOA) determinations, Request for Designation (RFD) submissions, and global requirements. Our Regulatory Affairs team develops tailored strategies, prepares robust submissions, and supports interactions with FDA, EMA, Notified Bodies, and other authorities to ensure your combination product advances efficiently from development through approval and lifecycle management.

  • Regulatory Strategy & Planning
  • Regulatory Submissions & Filings
  • Global Market Access
  • Lifecycle Management
  • Regulatory intelligence & Monitoring

We help clients define the most efficient regulatory pathway for their combination products. Our team supports regulatory assessments, filing option evaluations, and product designation strategies, including pre-RFDs/RFDs. We also guide expedited review applications such as Orphan Designation and Fast Track, and prepare clients for FDA interactions through strategic planning, briefing book development, and pre- and post-meeting support.

Kymanox provides expert support for global submissions, including INDs, BLAs, NDAs, and 510(k)s. Our team ensures that technical documentation is complete, compliant, and aligned with regulatory expectations to streamline approval and avoid delays.

Kymanox helps clients expand worldwide by managing Notified Body interactions, NBOp authoring and submissions, and regional regulatory engagement. With experience across FDA, EMA, MHRA, PMDA, and other global authorities, we ensure combination products are positioned for successful approval and distribution across multiple markets.

Combination products require ongoing regulatory oversight well beyond initial approval. We support lifecycle management activities such as design and process changes, documentation updates, and supplementary filings to keep products in compliance and on the market.

Our regulatory experts continuously monitor evolving guidance, regulatory trends, and competitor activity to keep clients ahead of change. We provide actionable insights that inform strategy and help anticipate agency expectations before they become roadblocks.

WHY THIS MATTERS

Partnering with Kymanox gives you access to deep regulatory expertise combined with practical, proactive support designed to streamline regulatory activities, reduce compliance risk, and accelerate your time to market. We tailor solutions for both global and local regulatory requirements, helping to navigate complexity with confidence and agility.

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Strategic Support

Accelerate combination product success with expert-guided development roadmaps, tailored to your business objectives and regulatory landscape. Kymanox delivers end-to-end strategic planning integrating regulatory, clinical, technical, and market insights to keep your program on track and reduce risk.

  • Comprehensive development roadmaps, from feasibility to commercialization. We align regulatory, clinical, CMC, usability, and technical milestones for clarity and speed.
  • Feasibility assessments and device-TPP alignment to ensure the right delivery system for your target product profile and market goals.
  • Market landscape and business case analyses providing actionable insights for competitive positioning and long-term value.
  • Integrated strategy support that bridges cross-functional gaps, harmonizes documentation, and manages vendors for smooth execution.
  • Proven best practices to accelerate launches, close technology transfer gaps, and minimize costly delays.

WHY KYMANOX

Clients benefit from a cross-disciplinary team with deep expertise in combination product development and regulatory strategy. Our support reduces resource gaps, clarifies complex requirements, and ensures programs meet milestones for faster approvals and sustained market success.

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Project Management

Drive capital project success with experienced project management and GMP leadership. Kymanox delivers strategic oversight and hands-on execution, guiding complex initiatives from business case development through facility build-out, equipment start-up, and full-scale production launch.

  • Strategic management of capital projects—from initial design through GMP-compliant operations.
  • Business case analysis and robust project justification for confident investment decisions.
  • Workforce and organizational planning, ensuring resources align with project timelines and goals.
  • Efficient supplier and partner sourcing, with coordinated management for seamless execution

Accelerate facility delivery and safeguard compliance with proven project management expertise that keeps projects on schedule and within scope.

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