Specialized Global Regulatory Expertise

Specialized Global Regulatory Expertise

Read the rest of our regulatory expertise series below:

• Part I: A History of Regulatory Expertise at Modality Solutions
• Part II: Why Outsource Regulatory Expertise?
• Part III: What Makes Modality Solutions Your Cold Chain Regulatory Experts?

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The Modality Solutions team has been focused on the biopharmaceutical cold chain for the last ten years, with life sciences experience well beyond that. Our regulatory expertise is deep and shines particularly in packaging design and qualification, shipment lane validation, drug product simulation testing, and supportive stability studies.

The team’s deep understanding of stability studies over a product’s lifecycle (and how that supports the overall transport validation design and execution) is additive to the more extensive drug product quality program.

Our regulatory approach combines all the expertise into a capstone validation planning document that confirms not only the foundational stability data but the validation work as well. Modality Solution’s expertise amplifies work done earlier in the development cycle.

Manufacturers must show continuity in the data collected and used to support regulatory filing. In essence, Modality Solutions helps teams use new data to emphasize the monitoring and control oversight to get teams through the last mile, the final key piece of the supply chain where it’s delivered to the patient.

In particular, the Modality Solutions team has significant expertise regarding global regulatory requirements.

Global Regulatory Requirements

Modality Solutions’ global expertise is rooted in a clear understanding of the patchworked global regulatory requirements across multiple agencies and jurisdictions. The team works with clients and pharma manufacturers to develop validation reports that meet the global regulatory requirements for the appropriate locations.

Historically, pharma manufacturers might launch a product in 10 countries and develop ten different approaches to meet these regulations. Instead, Modality Solutions seeks out commonalities and strategizes a method to address regulatory concerns or requirements most efficiently and effectively.

Most commonly, Modality Solutions sees two significant challenges in global regulatory requirements: China and Brazil, both countries requiring what Modality Solutions refers to as a “GlobalPlus” approach, where you’ll need foundational validation work for multiple jurisdictions plus specific jurisdictions.

Tip: Don’t get too specific in your validation approach.

A mistake many manufacturers make is identifying specific lanes, networks, carriers, or even thermal packaging that will be utilized throughout the cold chain in their filing. Identifying these specifics is a considerable risk. If any changes are made, they’ll need to add to their biannual or annual good manufacturing practices inspection or, in some cases, the change could be considered major and require prior approval. What’s better is to provide good validation practices in the filing, which detail the approach used and show in a supplemental report how those good practices were filed in the thermal packaging and current cold chain. That way, if you change packaging or lane routing, you don’t have to reopen the filing to submit those changes as long as you’re using the same approach.

Example:

In a specific case, a client took a rigorous approach in their original shipping validation (gel packs used in shipping – down to number and orientation). Their validation was so specific if there were any changes to the SKU, configuration, or internal design of the shipping container, they would need to refile with the agencies based on these changes.

This approach delays the entire process with the regulatory authorities, which is not optimal for your launch timelines. You want to validate shipping with strategic intent but not specifics, so you cover potential adjustments on shipping containers, gel packs, and so on – so all your bases are covered.

Modality Solutions had to standardize their validation approach procedure so their risks of requiring pre-approval were minimized. They had inherent flexibility in their shipping operational parameters – all validated by a more-thorough shipping validation plan.

Visit our Regulatory Filing Services for more information on how Modality Solutions provides phase-specific filing solutions you need to prepare your cold chain for a successful rolling submission, traditional filing, or expedited filing approach.

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