Regulatory Consultancy – Labfit

Regulatory Consultancy

Security Advisory

Cosmetic products

– Safety Report;

– Preparation of the PIF (Product Information File);

– Preparation and verification of Labelling;

– Registration with the CPNP – Cosmetic Products Notification Portal;

– Evaluation of the formula to support claims;

– Industrial licensing;

– Assistance with the Ecocert Cosmos Organic certification process;

– Assistance with the EU Ecolabel award process;

Medical devices

– Technical dossier for medical devices;

– Preparation and verification of labelling;

– Identification of compliance with regulatory requirements: manufacturer and authorised representative;

– Industrial licensing;

– Preparation of clinical data dossiers;

– Biocompatibility assessment and risk analysis;

– Preparation of post-market surveillance plan – Annex III;

– Registration of economic operators in Eudamed;

– Assistance with the UDI process;

Biocidal products

– Creation of technical data sheets;

– Regulatory registration of hand or surface disinfectant products;

– Preparation and verification of labelling;

– Family assessment;

– Verification of the impact of co-formulants;

– Industrial licensing;

Raw materials and ingredients

– Elaboration of technical sheet;

– Preparation of safety data sheet;

Pharmaceutical products

– Environmental Risk Assessment

Veterinary products

Herbal medicinal products (HMPC)

– Registration of traditional use of herbal medicines;

– Preparation and verification of the package leaflet;

– Preparation and verification of the Summary of Product Characteristics for Traditional Herbal Medicinal Products;

– Preparation and verification of compliance with technical and regulatory requirements;

– Preparation and assessment of compliance of primary and secondary labelling;

– Preparation of the Common Technical Document (CTD);

– Assistance with submission to INFARMED;

– Assessment of the therapeutic potential and safety of a herbal substance or preparation;

– Preparation of the rationale and assessment of potential environmental risks;

Food supplements

– Notification;

– Labelling assessment;

– Claim assessment;

– Operators registration in SIPACE system;

– Production authorization;

– Import and export authorization;