Revolutionary Cold Chain Management built on Global Reach and Multidisciplinary Expertise
Reliable cold chain management is more critical than ever in today’s fast-paced and interconnected...
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Modality Solutions is constantly scanning the environment for updates to regulations and guidance – assessing the changes and how they impact the validation process. By leveraging their vast expertise, the teams at Modality Solutions know the application side of the regulations and can often anticipate regulatory reactions to your validation plan and submission dossier.
On an ongoing basis, the team at Modality Solutions continues to refine their regulatory knowledge as part of their everyday interactions with regulators all over the globe in over 40 countries.
Being an engineering consulting firm working in this space, the Modality Solutions team has experience with almost every available modality, temperature range, supply chain network, and more. This practical, daily experience as regulatory experts gives the team unique insight to access to the current thinking patterns of regulatory agencies on how to meet cold chain regulations.
>>> Related Webinar: How to Respond to Cold Chain IRs
This expertise allows Modality Solutions to strategically assemble validation master plans, protocols, and data summaries in a report that meets (or often exceeds) the regulators’ expectations in multiple jurisdictions. We approach IR responses systematically with data and analysis using multi-disciplinary engineering skills:
Reliable cold chain management is more critical than ever in today’s fast-paced and interconnected...
read DetailsIn the ever-evolving landscape of the biopharmaceutical industry, Chemistry, Manufacturing, and Controls (CMC) services...
read DetailsThe global regulatory experts at Modality Solutions provide a detailed, tactical approach for meeting...
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