Material Needs Consulting is pleased to offer the following services to the pharmaceutical and medical device industries as well as raw material, container closure system, and component suppliers to these industries.

• Material Selection for Devices and Packaging
  • Consult with product development teams to ensure the best selection of plastics and elastomers
  • Recommend stabilizer and additive systems
  • Assist companies in dealing with unexpected changes to the polymer or additives used in marketed products
• Development and Implementation of Testing Protocols for Ensuring Safety and Performance of Materials
  • Material Characterization
  • Extractables and Leachables Testing
  • Biocompatibility Testing
    • USP <87>, <88>, <661>, <381> and ISO-10993
• Supply Chain Management
  • Qualify vendors of materials and establish specifications
  • Implement quality control programs
  • Change control management
  • Design release testing programs
• Regulatory Consulting
  • Drug Master Files
  • 510(k) submissions
  • Chemistry, Manufacturing, and Controls (CMC) consulting
• Become a “Vendor of Choice”
  • Help raw material, container closure system, and component suppliers differentiate their products from the competition to increase sales
• Virtual Project Management
  • Material Needs Consulting can be an integral component of product development teams.  “In-source” the material, polymer stabilization, and Extractables and Leachables expertise.
• Training
  • Customized training programs can be developed on any of our service offerings.