Sartorius: How to meet changing global requirements for new product lines
Rick Calabrese, Global Director of Corporate Quality Systems at Sartorius, tells us how to ensure you are on top of your regulatory strategy
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As companies expand into new product lines and markets, it is crucial that the global regulatory landscape is taken into consideration. Whether you are launching a new product, contemplating a change to the distribution strategy or looking to move an existing product line to a new market, a failure to consider the applicable regulations could lead to serious compliance issues.
To find out more about how to prepare for this scenario and ensure you are ready to adapt to changing global requirements, Pharma IQ spoke to Rick Calabrese, Global Director of Corporate Quality Systems at Sartorius.
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Rick believes that to manage this process in an agile way, there must be a full strategy in place. This should apply to all relevant teams, including product development, product management, operations, sales and marketing.
He suggests creating a comprehensive workflow process to connect these different functions so everyone is fully aware of their roles and the key areas to consider. In this process, he believes that “regulatory has to be the glue that holds it all together”.
As part of this process, Rick recommends introducing forms, check boxes and sign offs. This will allow the regulatory function to capture the necessary information in advance, research areas if needed and understand what plans are in the pipeline. For Rick, it is essential that regulations “reviews any product to be distributed outside of its normal distribution channels or new products in development”. It is essential that regulatory are consulted at the start and the impact of regulations considered during the process to avoid any errors.
One issue is that many teams assume that compliance efforts in one country can be mirrored in another. However, this is not the case. That is why it is crucial to have a global focus and ensure understanding of the full spectrum of requirements.
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Rick offers the example of the sale of pipettes. Due to a recent regulation change, these are no longer considered medical devices in Europe. However, in the US they are still Class I medical devices. Therefore, if you are a European company and you plan to expand your distribution strategy to the US you need to be aware of the difference in requirements so you can prepare to meet them.
As Rick reiterates, “no one should do anything – products should not be launched or distributed – without going back to regulatory affairs first”. He points out that one of the core issues is that too often these type of conversations do not happen early enough. This means that the team does not have enough time to adequately plan out their activity and ensure they are ready for the change.
Rick notes that there are consequences to this. As he explains, “if you don’t pay attention to this issue then, at best, when distributing your products they could be held up, or at worst, they could be sanctioned or fined”. There may also be civil action if the incident is serious enough.
The regulatory function is not intended to be a roadblock to activity. Rather, they exist to ensure that the company understands their full compliance needs for a product and are able to action this to ensure the long-term success of a product.
Rick shares that one of the biggest issues companies face is ethics. As he puts it “knowing when you have to say ‘no, you can’t do this’”. He expands that during the process “you try to find creative ways that the company can meet their goals and still be compliant, but there are time when there is no way that you can do something”. He believes that in such situations, it is important that the regulatory function has “the courage and conviction to go up and say ‘sorry you can’t do this’”. While this may be a tough situation, it is worth it in the long run.
If companies want to ensure regulatory compliance as they create, develop and expand their products, then there are three critical points. First, they must create concrete processes and ensure that relevant teams are following them closely. They must ensure that regulatory affairs is involved at the start of these conversations and throughout. Finally, all teams must keep the long-term regulatory implications front of mind.
