Serving Highly-Regulated Industries With High-Value & High Risk Products

Modality Solutions provides solutions-based thermal package engineering and controlled-environment logistics for highly-regulated industries with high-value, high-risk products, primarily the Biopharmaceutical and Nutrition, Health and Wellness industries. Our primary focus is on product and process improvements that provide insights to decrease product development cycle times and manage risks in the supply chain by testing packaging and product formulations against transport environmental hazards in our unique laboratory simulation setting.

We Need to Talk If You Are a . . .

  • Scientist or Innovator translating basic research into first-in-human (FIH) clinical studies.
  • Early-stage Innovator or Research-based Developer advancing candidates through commercial drug formulation.
  • Clinical Development and/or Translation Science Consultant supporting innovators and research-based developers progress early stage candidates and conduct clinical trials.
  • Biologics Drug Development Consultant assisting innovators and research-based developers in technology transfer, process development, manufacturing, and quality compliance in order to move from scale up into commercial manufacturing process design.
  • Industry Supplier providing thermal packaging design, and controlled-environment logistics products and services in support of clinical and commercial supply chains.

Engage Recognized Industry Thought Leaders

Our systems-based approach to process characterization, package design, transport validation, and quality systems development for specialized biopharmaceutical and healthcare industries, leverage our teamís key impressive skill sets:

Specific Disciplines Access specialized skills in pharmaceutical packaging, GMP/GDP quality systems, regulatory compliance, import/export, and controlled-environment logistics management.

ExpertiseBenefit with our Six Sigma Black Belt and LEAN Practices improvement experience, process validation, transport simulation, risk analysis, combined with proven logistics network design in the biotechnology arena that transcends current industry capabilities.

ExperienceGain value-added knowledge around cGDP compliance and regulatory inspections for packaging qualification and transport validation for controlled-environment logistics worldwide--with over a dozen marketing approvals and hundreds of successful inspections.

StrategyNavigate with confidence the decision making process to identify key regulatory issues, compliance concerns, and product quality risks. Facilitate the discussion to build consensus across the organization on a strategic path forward.

Our multi-disciplinary team is ready to help you with your cold chain needs or existing program. For more information, contact us today.