Why outsource regulatory expertise?

Why outsource regulatory expertise?

Why outsource regulatory expertise?

As a pharmaceutical manufacturer, your in-house experts can only get you so far during the filing process. Our in-house experts are focused on good packaging design and qualification. Our subject-matter experts offer your team both 1) drug product quality and 2) process validation to augment their packaging skill sets. By outsourcing our regulatory expertise, you can allow your teams to do what they do best while also taking care of these critical areas for successfully validating your cold chain.

In-house experts have invaluable knowledge but often lack frequent interaction with regulatory agencies, as the experts at Modality Solutions. For instance, if a company only submits biologics applications every 3-5 years, the regulations will change tremendously before the next submission. It helps to consult with a team that’s constantly conversing with regulators. Weekly interactions between the Modality Solutions team and regulators mean they are always up to date on agency expectations and regulatory changes.

What do CMC regulatory consultants miss?

Pharma manufacturers historically also work with regulatory consultants, but generalist regulatory consultants are often focused on a particular modality or the entire CMC section of the filing. While regulatory consultants understand the general strategy and are grounded on good regulatory practices, they often lack the expertise for cold chain, supply chain, and transport validation. We can help in these situations:

  • Insufficient information and data were provided to support an evaluation shipping validation. Provide information and data to support an evaluation of the potential impact of commercial shipment through each intended commercial shipping lane on product quality (e.g., biochemical stability).
  • Your protocols do not have analytical tests and acceptance criteria to assess the stability indicating product quality attributes of the shipped DP.
  • Provide the shipping protocol for the distribution of the finished product. Include the following: justification on the shipping lanes executed for the current shipping practices and acceptance criteria for evaluating the potential impact on DP quality.
  • The shipping protocol and results provided did not demonstrate temperature control during shipping. Provide a protocol for three shipping runs to demonstrate that temperature is maintained during worst-case shipping conditions. The study should include maximum and minimum loads unless a justification for a worst-case load is provided.


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