REGULATORY CONSULTING
COSM&TIC ASSIST Regulatory consulting
The key to success? The rules
A business strategy cannot fail to include a regulatory compliance plan. It is, in fact, an indispensable and essential requirement to ensure maximum success for any international or national strategy. Untangling laws, rules and regulations, too often difficult to interpret and read, requires the support of a team of experts. Cosm&Tic Assist offers expert regulatory consulting, throughout Italy and abroad. Rely on expert technicians for excellent results and a successful strategy.
PROFESSIONAL SUPPORT IN NUMEROUS AREAS
Cosm&Tic Assist operates in various areas, providing detailed regulatory support for businesses in the following sectors:
- Cosmetics: experts deal with safety assessment, PIF, CPNP, CLV, labelling, cosmetovigilance, International Regulatory Affairs Export/Certifications/RP. They ensure the ongoing support of a responsible person;
- Food, Supplements and Nutraceuticals: our company provides an experienced food handler for notification, labelling, certificates, claims, assistance and compliance, International Regulatory Affairs Export/Certifications;
- Medical devices: the regulatory consultancy plan provides for the management of technical, manufacturer/agent files and the support of a person responsible for the regulatory, supervisory, notification, International Regulatory Affairs Export/Certifications part;
- Pharmaceuticals: staff deal with marketing authorisation, dossier, CTD/e-CTD, summary of product characteristics, package leaflet, IA/IB/II variations, pharmaceutical product certificate, assistance and compliance, International Regulatory Affairs Export/Certifications.
- Chemicals, Hazardous Mixtures and Articles: technicians take care of reach registrations; CLP notifications; UFI notifications; EU and non-EU safety data sheets, information sheets, management and notification of articles (SCIP database), International Regulatory Affairs Export/Certifications; industrial advice on occupational safety, environment and waste; (RSPP) responsible for prevention and protection, industrial risk management (DVR), fire prevention, legislation and waste forms, training and training; dangerous goods transport consultancy: ADR; RID; IMDG; IATA;
- Detergents: the team follows each phase through timely regulatory consultancy linked to the management of UFI notifications, EU and non-EU technical and safety data sheets, International Regulatory Affairs Export/Certifications;
- Biocides: producing registration dossiers, authorisation applications, PA approval applications, labelling, assistance and compliance, International Regulatory Affairs Export/Certifications.
- Agrochemicals: consultancy for substances and products: Fertilizers, PPP – Plant Protection Product & Phytosanitary Products. International Regulatory Affairs (Export): EU.
- Eco-labelling/Environmental labelling (for europe markets)
Cosm&Tic Assist provides a thorough and comprehensive assistance plan, relating to European and non-European regulations.
Cosm&Tic Assist opera in diversi ambiti, fornendo una minuziosa consulenza regolatoria per le attività impegnate nei seguenti settori:
• Cosmetici: gli esperti si occupano della valutazione della sicurezza, del PIF, CPNP, CLV, etichettatura, cosmetovigilanza, International Regulatory Affairs Export/Certificazioni/RP. Garantiscono il supporto continuativo alla persona responsabile;
• Alimenti, Integratori, Nutraceutici: l’azienda mette a vostra disposizione un operatore esperto nel settore alimentare, che si occupa della notifica, etichettatura, certificati, claims, assistenza e conformità, International Regulatory Affairs Export/Certificazioni;
• Dispositivi Medici: Il piano di consulenza regolatoria prevede la gestione dei fascicoli tecnici, fabbricante/mandatario e del supporto di una persona responsabile per la parte normativa, di vigilanza, notifica, International Regulatory Affairs Export/Certificazioni;
• Farmaceutico: gli addetti si occupano dell’autorizzazione per immissione in commercio, dossier, CTD/e-CTD, riassunto caratteristiche prodotto, foglio illustrativo, variazioni IA/IB/II, certificato prodotto farmaceutico, assistenza e conformità, International Regulatory Affairs Export/Certificazioni.
• Chemicals, Miscele Pericolose e Articoli: i tecnici si occupano delle registrazioni reach; notifiche CLP; notifiche UFI; schede di sicurezza Eu ed extra-UE, schede informative, gestione e notifica articoli (database SCIP), International Regulatory Affairs Export/Certificazioni; consulenza industriale sicurezza sul lavoro, ambiente e rifiuti; (RSPP) responsabile servizio di prevenzione e protezione, gestione rischi industriali (DVR), prevenzione incendi, normativa e formulari rifiuti, formazione e training; consulenza trasporto merci pericolose: ADR; RID; IMDG; IATA;
• Detergenti: il team segue ogni fase attraverso una puntuale consulenza regolatoria legata alla gestione di notifiche UFI, schede tecniche e di sicurezza Eu ed extra-UE, International Regulatory Affairs Export/Certificazioni; biocidi, realizzando dossier di registrazione, domande di autorizzazione, domande di approvazione PA, etichettatura, assistenza e conformità, International Regulatory Affairs Export/Certificazioni.
• Agrochemicals: cosnulenza per sostanze e prodotti, Fertilizzanti, PPP – Plant Protection Product & Fitosanitari. International Regulatory Affairs (Export/Certificazioni) : EU.
• Etichettatura Ambientale (nazionale ed europea)