Be More Integrated.
Get More Done.

COMBINATION PRODUCTS


Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).


COMBINATION PRODUCT SERVICES


Kymanox provides turnkey services to bring your combination product from concept to commercialization and helps keep your product on the market. Kymanox provides technical expertise for combination products in the following areas:


    Kymanox - Combination Products
    • Product Strategy and Innovation

    • User Research and Technology Landscaping

    • Program and Portfolio Management

    • Drug, Device, and Process Development

    • Equipment Selection and Qualification

    • Analytical Method Validation

    • Primary and Secondary Packaging Development

    • Design Controls and Quality Management System

    • Risk Management and Gap Assessments

    • Supplier Selection, Auditing, and Management

    • Management of Human Factors Studies and Third-Party Laboratory Testing

    • Clinical Affairs and Pharmacovigilance

    • Clinical Evaluation Reports and Performance Evaluation Reports

    • Pre-Approval Inspection (PAI) Readiness

    • Commercial Launch Preparations

    • Product Lifecycle Management

    • Post-Market Surveillance and Support

    • Complaints Handling and Remediation

    • Change Control, Deviation, and CAPA Support

      Examples of Combination Product Expertise


      Small and Large Molecule Injectables Prefilled Syringes (PFS) Mechanical and Electromechanical Autoinjectors Wearable Injectors Dual Chamber Systems Reconstitution Systems Respiratory Combination Products Metered Dose Inhalers (MDI) Dry Powder Inhalers Nasal Sprays Ocular Combination Products Multi-Dose Containers Other Single-Use Injectables Integrated Health Technology

        Kymanox can provide guidance and support for the following current industry practices and regulations:

          • Design Controls and Design History Files

          • Delivery Device Reliability Strategies

          • Failure Mode Analysis and Fault Tree Analysis

          • 510(k) Submission

          • ISO 13485, ISO 9001, and ISO 14971

          • Medical Device Directive (MDD) 93/42/EEC

          • Medical Device Regulations (MDR)

          • IEC 60601

          • 21 CFR 820 and Part 4

          Kymanox - Combination products
          Biotechnology | Pharmaceuticals | Medical Devices | Combination Products