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.
Five Business Units to Navigate Complex Regulatory Landscapes
Chemsafe’s five specialised Business Units are led by highly experienced Senior Scientists, each focusing on a specific area of expertise. These units provide comprehensive technical, scientific, and regulatory support, guiding you from strategic planning to the submission of dossiers or expert reports, ensuring compliance across diverse regulatory frameworks.
BU CHEMICAL SERVICES:
Expert Support for Chemical Industry Regulations
The Chemical Services Business Unit specializes in providing expert advice on all regulatory requirements within the chemical industry. Our expertise includes compliance with REACH and CLP regulations, as well as the preparation of Safety Data Sheets (SDS), ensuring your products meet all necessary standards.
BU HEAD CHEMICAL
Francesca Fasano
f.fasano@chemsafe-consulting.com
BU PHARMA SERVICES:
Comprehensive Support for Pharmaceuticals
The Pharma Services Business Unit focuses on toxicological and pharmacological risk assessments, environmental impact evaluations, and scientific and regulatory consulting. Our expertise also includes advanced in silico evaluations, ensuring a thorough and innovative approach to pharmaceutical compliance and safety.
BU HEAD PHARMA
Marco Rodda
m.rodda@chemsafe-consulting.com
BU MD SERVICES:
Specialized Support for Medical Devices and Cosmetics
The MD Services Business Unit provides expert technical, scientific, and regulatory consulting for medical devices, in vitro diagnostic devices, and cosmetics. Our consultancy supports clients at every stage of the certification process, ensuring that products meet all current regulatory requirements before entering the market.
BU HEAD MD
Alessandra Iavello
a.iavello@chemsafe-consulting.com
BU FOOD SERVICES:
Expertise in Food Regulations and Compliance
The Food Services Business Unit specializes in food-related regulations and legislation, providing regulatory advice and comprehensive risk assessments for products intended for consumer tables. Our scientific and regulatory consultancy supports clients in the registration processes for new foods or ingredients, ensuring full compliance with current standards.
BU HEAD FOOD
Camilla Conto
c.conto@chemsafe-consulting.com
BU AGRO/BIOCIDES SERVICES:
Specialized Support for Biocides and Plant Protection Products
The Agro/Biocides Services Business Unit provides expert technical, scientific, and regulatory consulting for biocidal products and plant protection products. Our team supports clients at every stage of the registration process, ensuring compliance with national and European regulations for successful market entry.
BU HEAD AGRO/BIOCIDES
Silvia Bortolami
s.bortolami@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
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