Regulatory services for food supplements, cosmetics, medical devices and FSMPs

Bringing a product to market means complying with precise rules, which differ for each category and each country. At Inalme, regulatory compliance is one of the steps of our working method: our Regulatory Affairs team works alongside Research and Development, Production and Quality, checks compliance with current regulations and provides documentary support for placing the product on the market, in Italy and abroad.

Regulatory support is part of every contract manufacturing and private label project: with your own formula, with a formula custom-developed by our laboratory, or with one of our ready-to-customise formulas.

  • Check of the formula against the regulations of the target market
  • Label texts and claim verification
  • Notification of food supplements to the Italian Ministry of Health
  • PIF and CPNP notification for cosmetics
  • Technical documentation for medical devices under Regulation (EU) 2017/745 (MDR)
  • Export support: products we manufacture are sold in 36 countries
Design of a food supplement

Food supplements

We check that ingredients, dosages and dosage form comply with food supplement regulations, prepare label texts according to current rules and handle the notification to the Italian Ministry of Health before the product goes on sale.

  • Check of ingredients, botanical extracts and dosages
  • Labelling and claim verification
  • «Gluten-free» and «lactose-free» claims, verified in our laboratories with tests performed according to methods recognised by the Italian Ministry of Health
  • «Suitable for vegans» claim
  • Notification to the Italian Ministry of Health

Food supplement contract manufacturing

Cosmetics

Every cosmetic product sold in the European Union must comply with Regulation (EC) No 1223/2009. We prepare the PIF (Product Information File) and support you with the notification on the European CPNP portal. For other countries we check the requirements of the target market with you.

  • PIF under Regulation (EC) No 1223/2009
  • Support with CPNP notification
  • Label texts
  • Dermatological and microbiological tests, patch tests, nickel test, stability and challenge tests supporting the documentation
  • «Nickel tested» and «dermatologically tested» claims

Cosmetics contract manufacturing

Cosmetics quality control laboratory
Production controls for medical devices

Medical devices

Class IIa, IIb and III CE-marked medical devices are designed and manufactured by our Medical Device Division under an ISO 13485 certified quality system. Our Research and Development team supports you in designing the device and developing the technical documentation in compliance with Regulation (EU) 2017/745 (MDR).

  • ISO 13485 certified quality system (Bureau Veritas)
  • Technical documentation under Regulation (EU) 2017/745 (MDR)
  • Analyses and tests supporting the technical documentation
  • Compliance with European Union safety standards

Medical device contract manufacturing

Foods for special medical purposes (FSMPs)

FSMPs are a regulatory category between food and medicine, with their own rules on composition, labelling and notification, set by Regulation (EU) No 609/2013 and Delegated Regulation (EU) 2016/128. In Italy they must be notified to the Ministry of Health before sale and are listed in the national FSMP register.

  • Check of the composition against FSMP regulations
  • Label texts
  • Documentation for the notification to the Ministry of Health

FSMP contract manufacturing

Laboratory analysis for foods for special medical purposes
Inalme products ready for export

Export: selling abroad

The products we manufacture on a contract basis are sold in 36 countries, from Europe to the Middle East, from Africa to South America. Many rules are shared within the European Union; for other countries we check the requirements of the target market with you from the design stage.

  • FDA registration
  • KMCA approval (Kurdistan Medicines Control Agency)
  • Halal certification
  • GMP production and ISO 9001, ISO 22000 and ISO 13485 certifications

For international projects you have a dedicated contact, our export manager.

Our certifications

ISO 13485 Bureau Veritas
ISO 9001 Bureau Veritas
ISO 22000 Bureau Veritas
GMP Good Manufacturing Practice
FDA Registered
KMCA Kurdistan Medicines Control Agency
Ecosmetica Organic
NATRUE
Biologico UE
Halal

How we work, from formula to compliant product

The regulatory path follows the project from the start, not just at the end.

  1. Project analysis: product category, target market and the claims you want to communicate.
  2. Formula check: ingredients, dosages and dosage form against the applicable regulations.
  3. Analyses and tests: the finished product tests needed for the documentation and claim verification.
  4. Label and documentation: label texts, PIF, technical documentation or dossier, depending on the category.
  5. Market placement: notification and documentary support, with our Production, Quality and Regulatory Affairs teams working together.

Discover the Inalme production method

Frequently asked questions

We do: we prepare the label texts according to the regulations and handle the notification to the Italian Ministry of Health before the product goes on sale.

The PIF (Product Information File) is the file that Regulation (EC) No 1223/2009 requires for every cosmetic product sold in the European Union. The CPNP is the European portal where the product must be notified before sale. We prepare the PIF and support you with the notification.

Yes. We verify claims such as «gluten-free» and «lactose-free», with tests performed in our laboratories according to methods recognised by the Italian Ministry of Health, «suitable for vegans», «nickel tested» and «dermatologically tested».

Yes. We design and manufacture class IIa, IIb and III CE-marked medical devices, with an ISO 13485 certified quality system and technical documentation compliant with Regulation (EU) 2017/745 (MDR).

Foods for special medical purposes must be notified to the Ministry of Health before sale; the Ministry lists them in the national FSMP register. We support you in preparing the documentation.

Yes. The products we manufacture are sold in 36 countries. We check the requirements of the target market with you and provide FDA registration, KMCA approval and Halal certification. For international projects you have a dedicated contact, our export manager.

Yes. Regulatory support is part of every contract manufacturing and private label project, from design to market placement.

Have a product to bring to market?

Tell us about your project: the category, the target market and the formula, if you already have one. We will tell you which regulatory steps are needed and how we can handle them together.

Your request goes directly to our export manager, who will follow your project from the first contact.