GROWTH PLATFORM

Design Services

We provide design services to clients who need product and process development support for regulated devices and components.

Clarifier - RGB Green - Design (1000 x 350) - Tint 85

Design Services

Program Management
Design Engineering
Prototype Engineering
Process Engineering
Quality & Regulatory
Material Sourcing
Testing
  • Program Management

    We provide design services for clients who need product and process development support for regulated devices and components. This includes program management, with dedicated project managers, who are responsible for overseeing projects from concept development through commercialization.
    Features
    Rates

    Design & Development Plan

    Design Controls

    Validation Master Plan

    Project Management

  • Design Engineering

    We provide design services for clients who need product and process development support for regulated devices and components. This includes design engineering from concept development to commercialization.  
    Features
    Rates

    Electrical Engineering

    Mechanical Engineering

    Human Factors Engineering

    Industrial Design

  • Prototype Engineering

    We provide design services for clients who need product and process development support for regulated devices and components. This includes prototype engineering for alpha and beta prototypes.
    Features
    Rates

    Alpha Prototypes (looks like, may work like)

    Beta Prototypes (looks like, works like)

  • Process Engineering

    We provide design services for clients who need product and process development support for regulated devices and components. This includes process engineering to support new products and processes and manufacturing transfer.
    Features
    Rates

    Define Product & Process Requirements

    Specify & Procure Tooling and Equipment

    Process Verification & Validation (IQ, OQ, PQ)

  • Quality & Regulatory

    We provide design services for clients who need product and process development support for regulated devices and components. This includes quality and regulatory support from our quality management team.
    Features
    Rates

    Essential Requirements & Risk Analysis

    Design Control Documentation

    Manufacturing Documentation

    Inspection Protocols & AQLs

  • Material Sourcing

    We provide design services for clients who need product and process development support for regulated devices and components. This includes material sourcing support for raw materials and components.
    Features
    Rates

    Advanced Flexible Materials

    Chemicals

    Excipients

    Active Pharmaceutical Ingredients

  • Testing

    We provide design services for clients who product and process development support for regulated devices and components. This includes testing in our wet and dry test labs as well as third party testing.
    Features
    Rates

    Dry Lab - Tensile Strength, Peel Strength, Elongation, Seal Integrity, Leak, Dimensional Metrology

    Wet Lab - pH, Density, Viscosity, Titration, FTIR, Tensiometry, Endotoxin Testing, Shelf-life Studies

    Third Party Testing

     


Additional Features

The path to faster innovation requires deep technical expertise across multiple disciplines and involves more complex supply networks to access non-core capabilities. Our services enhance innovation by improving time to market, filling competency gaps, and increasing agility. We increase your likelihood of commercial success with our expertise in advanced materials, engineering, and advanced manufacturing. 

Advanced Materials

Advanced materials including flexible materials, tubing, molded components, and liquid media.

Engineering

Engineering for design and development across all commercial phases from concept generation to sustaining engineering. 

Advanced Manufacturing

Advanced manufacturing, including liquid formulation, complex assembly, and process automation for regulated devices and liquid media.

End-to-End Services

End-to-end services to fill competency gaps anywhere in your commercialization process.   

Integrated Services

Fully integrated services to improve responsiveness and agility during the commercialization process. 

Design for Manufacturability

Expertise and alignment of design and manufacturing increases the reliability of commercial success. 

Reliable Product Quality

Reliable product quality is the principal risk factor we mitigate through our quality and regulatory systems and over 40 years of experience.

Minimize Competency Gaps

Our sophisticated quality system and team provide expertise and risk mitigation by filling competency gaps in your non-core operations. 

Ensure Strategic Supply

We ensure strategic supplier relationships which provide business continuity and redundancy through additional locations, capabilities, and resources. 


Qualifications

GROWTH PLATFORM

Design Services

We provide design services for clients who need product and process development support for regulated devices and components.