Regulatory, scientific and toxicological consulting services designed to take you far.
Managing regulatory compliance of chemicals, pharmaceuticals, medical devices, biocides, agrochemicals, foodstuffs and cosmetics is a key step in reaching the Italian, European and international markets.
ChemSafe’s aim is to assist the operator in these areas by simplifying the regulatory process to be followed and providing a correct product management strategy. The customisation of any scientific-regulatory advice is a necessary requirement to operate in today’s world and is fulfilled and offered from the very first meeting with our staff.
Four Business Units to lead you across multiple regulatory environments
Le ChemSafe Business Units are 4 areas of specialised expertise coordinated by highly experienced Senior Scientists, each of them offering comprehensive technical, scientific and regulatory support from strategy definition through to submission of the dossier or expert report.
BU CHEMICAL SERVICES
Division of ChemSafe that offers advice on all regulations related to the chemical industry in general, i.e. REACH, CLP, and preparation of SDS.
BU HEAD CHEMICAL
Francesca Fasano
f.fasano@chemsafe-consulting.com
BU PHARMA SERVICES
Division of ChemSafe specialized in toxicological and pharmacological risk assessment, environmental impact assessment, scientific and regulatory advice and in silico evaluation.
BU HEAD PHARMA
Marco Rodda
m.rodda@chemsafe-consulting.com
BU MD SERVICES
Division of ChemSafe specialising in providing technical, scientific and regulatory advice in the fields of medical devices, in vitro diagnostic devices and cosmetics. The purpose of consultancy is to support customers at all stages of the certification process to ensure that products placed on the market comply with current regulations.
BU HEAD MD
Alessandra Iavello
a.iavello@chemsafe-consulting.com
BU FOOD SERVICES
Division of ChemSafe dedicated to all food-related regulations and legislation, offering regulatory advice and careful risk assessment of products that may end up on our tables. The purpose of scientific-regulatory consultancy is to support the customer in the registration procedures for new foods or ingredients.
BU HEAD FOOD
Camilla Conto
c.conto@chemsafe-consulting.com
Integrated services for the safety and proper management of products placed on the market.
Chemical Products
Our consultants will guide you through the complex regulatory framework, helping you to properly manage chemicals in compliance with current legislation.
Biocides
Existing regulations (EU, national and UK) in the field of biocidal products require very complex activities, ranging from preliminary formulation evaluation, efficacy and risk assessment to dossier development.
Plant Protection Products
Existing EU, national and UK regulations in the area of plant protection products require specific activities that include technical and registration advice, risk assessment of different types of formulations, and the preparation of dossiers.
Pharma
The ChemSafe team provides comprehensive support throughout the entire lifecycle of the drug, whether for human or veterinary use, assessing product safety and regulatory compliance.
Cosmetics
Our priority is to ensure that the products on the market are safe for the end consumer and in compliance with current regulations. Our team is also able to support manufacturers from raw materials through to finished product marketing and lifecycle management.
Medical Devices
We support manufacturers in drafting the complex technical documentation required to design, develop and market their devices. We also support the various economic operators in implementing a quality management system that complies with the relevant regulations. As ChemSafe, we are able to fulfil the role of Responsible Person for Regulatory Compliance.
Food
We offer specialist consultancy services in the food sector, especially regarding novel foods, ingredients, food supplements, botanicals, and packaging (Food Contact Materials).
We help with the European authorization procedures for new food ingredients (additives, enzymes, flavorings) and Novel Food from the scientific-regulatory strategy to the dossier submission.
Our support is strongly scientific.
Training
Mettiamo a disposizione di ogni nostro cliente il nostro know-how in ambito tossicologico e regolatorio attraverso mirate attività di formazione.
Archive
Our Archive: dedicated person, mobile shelving system, controlled physical and e-access...