Consulting

Food supplements

  • Drawing up and review of the formulations

      After the drawing up of the formulation of the active components, we proceed with the complete analysis and the review of the formulae there is a verification of the acceptance from a regulatory point of view of the additives used by the producer.

  • Drawing up of the legal texts of the boxes

    • Drawing up of texts of the packaging materials based on current laws
    • Investigation on the most appropriate directions for the product

  • Review of the instructions leaflets and several materials

    • Review or drawing up of the explanatory papers, technical cards
    • Review of the leaflets for public and informative material generally addressed to both the consumers and professional operators.

  • Drawing up of scientific reports

    • Review and correction of scientific and rational nutritional reports in support of the indications from the various product

  • Drawing up and testing of products dossier

    • Drawing up and / or review of the technical dossier provided for by EFSA guidelines for food for particular nutritional uses

  • HACCP Manuals

    • Checking of HACCP manuals and participation in self-inspections for the manuals verification
    • Collaboration on the drawing up of the layout relating the workshop production

  • Good Manufacturing Practice Manuals

    • Verification of Good Manufacturing Practice Manuals and inspection for verifying the implementation of the various operational procedures

  • Notification of the labels at the Ministry of Health

    • Hand delivery to the Ministry of notification letters with a stamp stating for the certain date of the notification

  • Monitoring Ministerial practices

    • Assistance until the conclusion of the practice with the inclusion of the product in the appropriate Registers published on the Ministry's website

  • Representation at the Ministry of Health

    • Representation of the customer company as a prosecuting attorney at the Ministry of Health for the delivery and withdrawal of various documents and for case management

  • Request of certificates and various attestations

    • Presentation of Free Sale Certificates and withdrawal of the same at the Ministerial offices

  • Regulatory Update

    • On-line service of new regulations update issued in Italian and European level (accessible via credentials delivered at the time of signing the contract)

  • Research of qualified suppliers

    • Search for suppliers of raw materials and finished products

  • Audits at suppliers

    • Validation audit at suppliers of raw materials and finished products

  • Assistance

    • Assistance concerning the products for any disputes that may arise with regulatory bodies such as NAS, ASL, Ministry, etc.

Foods for Particular Nutritional Uses

  • Verification of the formulations

    • Verification of the active components in relation to the type of product (AFMS products for infants)
    • Verification of the acceptability from a regulatory point of view of the additives used by the producer

  • Drawing up of the legal texts of the boxes

    • Drawing up of texts of the packaging materials based on current laws
    • Research of the most appropriate directions for the product

  • Review of the instructions leaflets and several materials

    • Review or drawing up of the explanatory papers, technical cards
    • Review of the leaflets for public and informative material generally addressed to both the consumers and professional operators.

  • Drawing up of scientific reports

    • Review and correction of scientific and rational nutritional reports in support of the indications from the various product

  • Drawing up and testing of products dossier

    • Drawing up and / or review of the technical dossier provided for by EFSA guidelines for food for particular nutritional uses

  • HACCP Manuals

    • Checking of HACCP manuals and participation in self-inspections for the manuals verification
    • Collaboration on the drawing up of the layout relating the workshop production

  • Good Manufacturing Practice Manuals

    • Verification of Good Manufacturing Practice Manuals and inspection for verifying the implementation of the various operational procedures

  • Notification of the labels at the Ministry of Health

    • Hand delivery to the Ministry of notification letters with a stamp stating for the certain date of the notification

  • Monitoring Ministerial practices

    • Assistance until the conclusion of the practice with the inclusion of the product in the appropriate Registers published on the Ministry's website

  • Representation at the Ministry of Health

    • Representation of the customer company as a prosecuting attorney at the Ministry of Health for the delivery and withdrawal of various documents and for case management

  • Request of certificates and various attestations

    • Presentation of Free Sale Certificates and withdrawal of the same at the Ministerial offices

  • Regulatory Update

    • On-line service of new regulations update issued in Italian and European level (accessible via credentials delivered at the time of signing the contract)

  • Research of qualified suppliers

    • Search for suppliers of raw materials and finished products

  • Audits at suppliers

    • Validation audit at suppliers of raw materials and finished products

  • Assistance

    • Assistance concerning the products for any disputes that may arise with regulatory bodies such as NAS, ASL, Ministry, etc.

Cosmetic products

  • Drawing up of the texts of the boxes

    • Drawing up / checking of the composition of the product and descriptive texts of the packaging in accordance with current regulations on cosmetic products.
    • Identification of the allowed claims

  • Verification of informative and advertising materials

    • Verification of the texts of illustrative leaflets, informational sheets for operators in the sector, informational brochures for consumers and advertising messages in general

Medical devices

  • Verification of the formulations

    • Verification of the correspondence of the composition of the product with the regulations

  • Verification of the class

    • Verification of the correct classification of the product according to the various classes

  • Verification of the product dossier

    • Verification of the product dossier according to the regulations

  • Drawing up of the legal texts of the boxes

    • Identification of the allowed and appropriate directions for the product
    • Drawing up of the texts of packaging materials according to the regulations

  • Verification of illustrative leaflets

    • Revision or drawing up of explanatory leaflets

  • Inclusion in the database

    • On-line insertion of the product in the database of medical devices

  • Advertising materials

    • Revision of promotional materials for the public and for health workers

  • Request for certificates and attestations

    • Presentation of requests for advertising authorization
    • Presentation of requests and withdrawal of free sale certificates

  • Representation at the Ministry of Health

    • Representation of the custumer company as a prosecuting attorney at the Ministry of Health for the delivery and withdrawal of various documents and for case management

  • Research of qualified suppliers

    • Search for suppliers of raw materials and finished products

  • Assistance

    • Assistance concerning the products for any disputes that may arise with regulatory bodies such as NAS, ASL, Ministry, etc.

Novel food

  • Verification status of raw materials

  • Assistance for authorization practices

  • Verification of authorization dossier

Manufactoring

  • HACCP Manuals

    • Checking of HACCP manuals and participation in self-inspections for the manuals verification
    • Collaboration on the drawing up of the layout relating the workshop production

  • Good Manufacturing Practice Manuals

    • Verification of Good Manufacturing Practice Manuals and inspection for verifying the implementation of the various operational procedures

Training courses

  • Technical and regulatory training courses for agents

  • Training courses for sales force, marketing employees and R & D

Assistance

  • Assistance regarding the products and establishments for any disputes that may arise with regulatory bodies such as NAS, ASL, Ministry, etc.

Other services

  • Provision soft gelatin capsules third parties

  • Participation as a speaker in updating courses on technical and regulatory aspects of food supplements and dietary products

  • Constant updates regarding the new Italian and European regulations concerning food supplements, dietary and cosmetic products

    • These updates are promptly incorporated in the area reserved for Dialfarm’s customers which can only be accessed via password