Products & services

Petitioning for FCM

We understand that you have a lot invested in your product. This means that when you come across a non-listed substance which requires approval before placement on the market, you need expert support. That’s where we come in.

Our decades of experience in compiling petition dossiers that can convince authorities makes us the perfect partner for guiding you in this daunting process – no matter the material.

With experience in both European legislation and national regulations, you can rely on our professional expertise. Want to place a product on a market outside of the European Union? No problem: we can assist you in filing a dossier for the FDA or advise you on countries outside of the EU.

Throughout the entire petitioning procedure, you can rely on our expert regulatory and toxicological support. Not only do we advise you on the setting up of a test protocol, but we also help you in choosing which test samples to prepare. All required migration tests can be readily performed in-house using our state-of-the-art analytical equipment.

These tests include the determination of reaction products, oligomers and decomposition products related to your substance. We also have the capabilities to perform decomposition tests, such as hydrolyzation studies. When necessary, we can commission and manage any relevant toxicology studies.

Of course, our work doesn’t end following the submission of your petition dossier to the relevant authorities. We continue to assist you in responding to the authorities and in subsequent communication on your behalf.

All of our petitioning projects are customized to meet your needs. Our regulatory and analytical experts can advise you on the complete process.

Get in touch with Mireille:

Slide Innovators of ONE HEALTH In the race to market, time is critical, as is your careful investment of resources. You deserve a strategic, Read more

Knowledge center

Learn more about the world of laboratory research! Find out why we provide the best solutions for even the most difficult researches in the fields of pharma, food, feed, chemistry and more.
Stay informed

Extend your knowledge here!