“Not being compliant to relevant regulations could severely damage customer relations, and even the company’s reputation.”
Jan Arnauts

A new product should be safe for human health and the environment, compliant with relevant regulatory regulations and preferably possess other product properties that increase its benefit or profit e.g. contributing to a circular economy, or restoring a patient’s health. In addition, the product should possess the same basic properties every time it is produced. Developing a product that meets all these requirements and drafting a strong business plan for it, is quite the challenge. InSciTe asked Jan Arnauts, Regulatory Affairs Polymers at DSM, for advice. 
 

“Ideally, Regulatory, Quality and Intellectual Property consultants would be involved from the very start of product development. Realistically, it is recommended to get them involved as soon as a concept Business Model is available.”

“Not being compliant to relevant regulations could severely damage customer relations, and even the company’s reputation.” - Jan Arnauts

A new product should be safe for human health and the environment, compliant with relevant regulatory regulations and preferably possess other product properties that increase its benefit or profit e.g. contributing to a circular economy, or restoring a patient’s health. In addition, the product should possess the same basic properties every time it is produced. Developing a product that meets all these requirements and drafting a strong business plan for it, is quite the challenge. InSciTe asked Jan Arnauts, Regulatory Affairs Polymers at DSM, for advice.

“Ideally, Regulatory, Quality and Intellectual Property consultants would be involved from the very start of product development. Realistically, it is recommended to get them involved as soon as a concept Business Model is available.”

“Regulations are numerous and apply not only on end-products, but also to raw materials, shipment, importing a product into a different country (e.g. FDA approval in the US), etc.” says Arnauts. It is safe to say that it’s not always easy for a scientist or entrepreneur to know which regulations are relevant and which not. A few things to keep in mind:

1. Get clear what it is you are bringing onto the market, e.g. is it a chemical, material or technology, what is the intended use, and what are the volumes.
2. Determine in which countries you would like to sell your product or technology. Requirements differ per region or country.
3. State clearly who does what. Will you produce and ship the product yourself, or will the product be shipped by the customer or a third party? Create open and transparent communication down the chain, to guarantee that all parties are aware of their responsibilities and hold all the required documents.
4. Ask Regulatory Affairs for advice. Some registrations can take several months to years depending also on the product volume, region or application. There are some exceptions to regulatory requirements under specific conditions. Consulting a Regulatory Affairs Specialist could advise you regarding these exceptions, which could reduce the required time and tests for regulatory compliance.

Not being compliant is not an option. Arnauts describes some of the consequences: “Samples or shipments can be blocked at customs, illegal products on the market can be withdrawn by local bodies, fines can be high and companies risk being banned from the market. Ignoring certain regulations even falls under a criminal act. This could severely damage customer relations, and even the company’s reputation.”

​Want to know more? Jan Arnauts is involved in InSciTe’s training and education program. Visit the InSciTe website to explore which trainings could be relevant for you.

 

Compliance rules

 

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Compliance Rules

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