Regulatory Filing Support
Your products will use cold chain transportation across the globe. Environmental hazards can affect their quality. Our goal at Modality Solutions is to design and validate cold chain transportation for products which includes a validation master plan, protocols and reports, and summary of your process validation for regulators around the world.
Relax. We can handle it.
- Formulation testing
- Drug qualification
- Simulation testing
- Cold chain transportation
- Regulatory compliant
Cold Chain Transportation Validation
Modality Solutions provides experience and value-added know-how on cold chain transport validation of your controlled-environment logistics worldwide. Over a dozen marketing approvals and hundreds of successful inspections prove it. A manufacturer needs to provide product and process validation data to demonstrate product quality can be maintained during transport in the cold chain.
Drug Product Operational Qualification
Increasing regulatory scrutiny on global cold chain transportation means more product data will be required to show that the stress introduced during transport does not impact product quality or reduce shelf life. Current static accelerated stability studies will need to be augmented with distribution stability studies. Use our transport simulation technology to understand the impact on your drug product.