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PRODUCT DEVELOPMENT


Kymanox experience and knowledge across pharmaceuticals, biologics, medical devices, and combination products makes our Development team better in each of these areas. We integrate product and process development to create practical and speedy solutions. Our holistic and patient-centric approach ensures that the right products are developed for unmet patient needs.

Turnkey Product Development Support


Kymanox’s broad experience and integrated development approach ensures Right First Time products for unmet patient needs in accordance with US FDA, EU EMA, and rest of world regulatory requirements. Our forward-thinking approach to the product development lifecycle accesses both industry-leading technologies and disruptive innovations to position products for commercial success.

Kymanox uses comprehensive project management tools to support the Development team, which can be “right-sized” to your project. Our technical project managers partner with our Product Development leads to capture project milestones, detailed timelines, and track the scope, schedule, and budget to ensure project objectives are achieved.



Product Development

PRODUCT DEVELOPMENT CAPABILITIES


The Kymanox Development team provides support in the following areas:


  • Identification of User and Patient Needs

  • Development Pathway Road-Mapping

  • Creation of Target Product Profiles (TPP) and Quality Target Product Profiles (qTPP)

  • Competitive Intelligence, Research, and Analysis

  • Technology Scouting and Assessments

  • Business Case Development

  • Medical Device Prototyping and CAD Support
  • Product Requirements Development

  • Quality by Design (QbD) Process Guidance

  • Production Equipment Evaluation, Selection, and Design

  • Production Process Development and Management

  • Project Execution Management

  • Integration with User Experience Solutions and Analytical Sciences

Your Life Science Solutions Partner For Product Development

Biotechnology | Pharmaceuticals | Medical Devices | Combination Products