Regulatory Consulting

A support for every need through the expertise of professionals in the sector, to fulfill regulatory requirements - satisfying our clients' needs.

Regulatory ConsultingRegulatory Affairs

Each customer is constantly supported by our Regulatory Affairs Department in every step of the product development process.

Compliance with standards and regulations is essential to ensure the safety and efficacy of products intended for the nutraceutical and cosmetic markets. Our in-house Regulatory Affairs Department works to ensure regulatory advice at every stage of the process, from design to commercialization, verifying that each product is in line with international standards.

In our commitment to provide comprehensive service to our customers, Alsa Lab’s Regulatory Affairs Department assist all partners to prepare all the necessary documentation for technical and safety dossiers, making sure to notify the Ministry and CPNP.

In addition, we offer guidance regarding the rules and regulations dictated by official guidelines in Italy, Europe and various international countries. Product labeling will be carefully evaluated to ensure compliance with current regulations, in collaboration with our Graphic and Packaging Department,responsible for the creation of packaging materials.

The drafting of the P.I.F(Product Information File) or technical files will be taken care of by our team to ensure the highest level of safety and regulatory compliance.

Regulatory Consulting

Scientific Support

Science Reliability for Effective Communications in the Nutraceutical and Cosmetic Markets.

To ensure verification of product efficacy, it is essential to conduct extensive literature researches, consulting European databases to find studies that offer clear scientific evidence and data to support recommended doses to achieve specific desired effects. In addition, it is important to focus on analyzing the scientific evidence on the ingredients in the product so that claims can be validly supported.

This helps provide the client with official and reliable scientific studies on product ingredients, thus solidifying the brand reputation and the accuracy of information offered to potential customers.

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Technical documentation for raw materials

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Technical files by product category

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Declarations of compliance with current regulations

Regulatory ConsultingServices Offered

Our Services: Tailored Solutions for Your Success
Conformity Evaluation
We analyze the regulatory side of your products with applicable regulatory and regulatory standards, identifying potential risks and providing recommendations to achieve full compliance.
Drafting Documentation
We produce all the necessary technical documentation required by current regulations, ensuring that product information is immediately available to the competent authority.
Regulatory Adjustment
In case of regulatory adaptations, we provide periodic updating of technical documentation supporting the product and graphic labeling.
Labeling and Claims
We support you in creating accurate and compliant labels, ensuring the correct presentation of product information, including health claims and nutrition claims.
Registration and Notification
We handle the registration and notification of your products with the relevant authorities, as required by current regulations, ensuring that documentation is complete and accurate.
Support for Regulatory Issues
In the event of an emergency situation or product recall, we provide support to manage communications with the relevant authorities and take the necessary steps to deal with the problem effectively.

Want to learn more? Contact Us!

If you are looking for a reliable partner for the creation of your product, get in touch for a personalized consultation on formulation and production.

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    Quality
    Certifications
    • ISO 9001:2015
    • ISO 13485:2021
    • ISO 22716:2008 Cosmetic GMP
    • GMP Food
      FDA (TITLE 21 – CFR CH I – PART 111)
    • Bio Cosmetics
    • Halal
    • Kosher
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    Our Partners
    Affiliated with
    Quality
    Certifications
    • ISO 9001:2015
    • ISO 13485:2021
    • ISO 22716:2008 Cosmetic GMP
    • GMP Food
      FDA (TITLE 21 – CFR CH I – PART 111)
    • Bio Cosmetics
    • Halal
    • Kosher
    Follow Us
    Alsa Lab Social Links

    © 2024 Alsa Lab S.r.l. Società Benefit. VAT number: 06896511216. All rights reserved.

    © 2024 Alsa Lab S.r.l. Società Benefit. VAT number: 06896511216. All rights reserved.

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