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
Food supplements
– Notification;
– Labelling assessment;
– Claim assessment;
– Operators registration in SIPACE system;
– Production authorization;
– Import and export authorization;
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Send an email to business@labfit.pt for more information about how we can help your project grow.
