No fuss, no muss… Legisana is here!

Our business lines

Legisana is at your service throughout Europe, from our offices in Belgium and France.

More than a hundred companies active in the food supplements and wellness sectors already appreciate our advice in designing their formulas and registering their product ranges with the authorities in Belgium, France and other member states.

your customisable regulations, whatever your product

A food supplement is a foodstuff whose purpose is to supplement the diet by providing a concentrated source of nutrients and which is marketed in dose form (capsules, pastilles, tablets, etc.) or which can be taken in measured units of small quantities (DIR 2002/46).

A medical device is a healthcare product that performs its action by physical or mechanical means. There are three categories of devices: medical devices, in vitro diagnostic devices (IVDs) and active implantable medical devices (AIMDs). (Regulations (EC) N° 2017/745 and 2017/746)

Cosmetic product” means any substance or mixture intended to be placed in contact with the superficial parts of the human body or with the teeth and oral mucous membranes in order to clean them, perfume them, modify their appearance, protect them, maintain them in good condition or correct body odors. (Regulation (EC) n°1223/2009)

Our pets have become such an important part of our lives… and our hearts… that we want to keep them as healthy as possible for as long as possible! Gone are the days of the doghouse at the bottom of the garden and leftovers in the bowl!

Food supplements have therefore quite logically developed in this sector, as complementary foods or dietetic foods (nutritional foods with a particular nutritional objective), phyto ranges… essential oils… But these supplements for pets are also governed by regulations…. which are harmonized at European level.

Animal feed regulations are completely different from those for human food, and labelling is in some ways more complex.
We have analyzed and synthesized these regulations, which sometimes require a good deal of interpretation!

Legisana

  • helps you launch your pet food range (dog, cat, rabbit, bird, etc.),
  • helps you check the conformity of your pet products and labels,
  • helps you register your company with the appropriate authorities,
  • helps you compile authorization applications for new ingredients (additives such as new plant extracts, essential oils, new substances, etc.).

    Contact us and let’s talk!

We are present at every stage of your product's development
step 1
idea

Whether you have the idea... or not, we're here to help you turn your dreams into reality! A natural cosmetics range with propolis? Spirulina-based dietary supplements? A soothing mallow syrup? Iron-enriched cat food? We'll help you make sense of the regulatory feasibility, status, communication and, above all, the budget.

How do I formalize my product idea?
Can I use this ingredient? Is it effective?
If so, at what dose? What is the maximum dose?
What will I be able to say about it on my labels, on my website?
What is the authorized target population for my product?
What tests should I carry out on my product?
What are the constraints in terms of production and quality for the product I want to market?

Of course, we can help you answer these and other questions!

You are starting your business, the size of your company does not yet allow you to have an in-house regulatory department... Call on our skills portage service! We'll take care of all your regulatory formalities to ensure perfect control over the quality and safety of your products.

step 2
formulation

Known and recognized as a "food supplement designer" for many years, Gilles helps you formulate your food supplement according to your wishes in terms of composition, concentration and budget. And all in compliance with the regulations of the country where you wish to market your dietary supplement. We can also assist you in terms of cosmetic formulation to obtain a cosmetic that is stable, pleasant to use and compliant with European regulations.

Is my star ingredient soluble?
Are the concentrations of ingredients used safe and effective?
Can I put this ingredient in a capsule? a capsule?
How effectively is my cosmetic preserved?
How do you formulate a stable product?
Is the packaging I've planned suitable in terms of stability and regulations for the product I want to put in it?

Of course, we can help you answer these and other questions!

step 3
regulations

Whatever the legislation in force (dietary supplements, cosmetics...), regulatory constraints are becoming increasingly onerous at both national and European level. Cosmetics and medical devices legislation is European, while dietary supplements legislation is mainly national.

However, nutritional and health claims are harmonized at European level...Navigating this knotty mess requires a good dose of skill, but also resilience! It's not enough to know the laws in force, you also have to interpret them, and be in constant contact with the authorities for the tolerances, derogations and flexibilities that are granted!

Does my packaging comply with the regulations in force in the country where it is sold?
What about claims on my website? Are they allowed?
Should I register my food supplement or cosmetic? If so, how?
What legal documents need to be drawn up?
What are the constraints from a quality point of view?
Who is legally responsible for my product?
Are the doses used in my product authorized for this ingredient?

We'll help you answer these and other questions!

step 4
production

Whether you want to produce yourself or outsource, we're here to help!

  • Do you have a production line for dietary supplements and cosmetics? Perfect! We can help you with a quality audit of your production line to ensure compliance with current standards.
  • You don't have your own production line but would like one? Don't worry, we'll guide you through all the regulatory and quality requirements prior to installation, to ensure that your production line complies with national and European legislation.
  • You don't want to produce your own food supplements or cosmetics? All right! We can produce them for you!
  • Do you already have a manufacturer in mind? We can audit them to make sure they supply you with quality products and comply with ISO standards for cosmetics, food supplements and medical devices.
step 5
registration

Legisana registers food supplements, cosmetics and medical devices throughout Europe.

The registration of food supplements remains a national competence, while that of cosmetics and medical devices is managed by Europe.

For dietary supplements, each web portal has its own specific features, and each member state requires specific information and files.

Cosmetic registration is more accessible, but the product information file and safety report are long and complicated regulatory documents that require a good knowledge of the regulations.

Don't panic! We're here to help you through the maze.

step 6
market launch

we can help you set up structured, authorized communication for your products, whether on your packaging, your website or your communication materials.

Once your products have been placed on the market, we can also provide you with a regulatory watch, so you'll be notified directly of any changes in legislation affecting your products!

Our skills

We can also help you with…

Focus on marketing your product, Legisana will work with your teams to take care of formulation, compliance with legislation and even production! That's the peace of mind of a true full service!

Copywriting

website and
external communication

We write and formalize your communication, both on your website and on your leaflets for professionals or customers. And all in compliance with the regulations governing the communication of your products.

Claims

That’s right! Unfortunately, we can’t say what we want! For dietary supplements, what you can say about an ingredient will depend mainly on the plant part used and its dosage. For some ingredients, any claim whatsoever is even forbidden! But fortunately, if you entrust us with the file as soon as your idea emerges, we’ll alert you upstream as to which claims can and cannot be used.

Label control

We write and formalize your communication, both on your website and on your leaflets for professionals or customers.

Product testing

We’ll advise you on which tests to carry out on your products, which are essential for drawing up legal documents, which are strongly recommended for your product, and which are superfluous. We warned you! Legisana is made to measure!

Regulatory watch and vigilance

We keep a close eye on the latest regulations, so you can rest easy! If the legislation changes and it affects your product, you’ll be the first to know!

Sourcing ingredients

Do you have key ingredients for your future product? We can source them for you. Would you like to supplement your product with other ingredients, preservatives or excipients? We also smile at them!

Quality audits

We can audit your own processes or those of your manufacturer! It’s up to you! Our aim: to guarantee impeccable quality in the manufacture of your products, whether or not they are subcontracted!

Supplier audits

When you order a new ingredient, you often receive a sample along with an analysis report and a technical data sheet. But how do you know if your supplier is really trustworthy? We can audit your supplier(s) to check that they comply with Good Practices in terms of sourcing, conservation, manufacturing, storage and shipping of your raw materials.

Production line

If you don’t want to produce your range yourself, no problem! Legisana produces your cosmetics and dietary supplements… or recommends a manufacturer!

Training your teams

We train your sales teams in the latest authorized claims. We train your production staff in good manufacturing practices. We train your analytical laboratory to perform the right tests on your products

Contact management
with the authorities

Legisana is in constant contact with the Belgian and French authorities to ensure a smooth link between you and the supervisory authorities. And, of course, we can handle your inspections, whether scheduled or unannounced!

We're here to help!

Whether you prefer an e-mail, easier for a first contact,
or a more direct phone call to explain your project, Legisana is available to answer your questions.