Specialized Cold Chain Expertise to Speed Your Client’s Regulatory Approval

How Modality Solutions Can Help

From individual consultants to large firms, regulatory affairs professionals regularly tap into our proprietary transport simulation lab—the only independent lab equipped to test multiple, concurrent, worst-case scenario hazards. We’ve generated more FDA-reviewed data through our lab than most pharma and biotechs have in decades of filing experience. And we have a proven track record of providing transport validations that remediate FDA information requests and 483s.

We provide subject matter expertise and support for two key FDA CTD (Common Technical Document) Sections required for regulatory submissions:

• Section 3.2.P.3.5 - Process Validation. We focus on distribution and cold chain requirements like packaging qualification (primary, secondary, and thermal) and drug transport simulation testing (including defining the distribution network and demonstrating drug product robustness).
• Section 3.2.P.8.3 - Stability Data. We focus on distribution and cold chain requirements like evaluating the effects of temperature excursions on drug product stability.

How Modality Solutions Can Help

We can enhance and strengthen your due diligence by assessing and validating a prospective company’s cold chain capabilities upfront, so you can avoid taking on unduerisk. And once you have made an acquisition or investment, we can apply our cold chain expertise as your operating partner—keeping the clinical development work moving toward FDA approval fast and effectively.

Modality Solutions can even bring our cold chain expertise to your life science investment community. We regularly address biopharma investment groups on the value of transport simulation technology for early drug formulation testing, especially for advanced therapeutics like CAR-T cell therapy and other biologics.