EU Regulatory Services
Since its establishment in 1989, SCC has risen to become one of Europe's largest regulatory consulting companies providing professional advice for the European market. During this time, we have meticulously built on, enhanced and updated our in-house expertise, making a name for ouselves as a renouned and trusted partner of the chemical industry.
Agrochemicals & Biorationals
Since 1989, SCC has been providing regulatory and scientific support for all types of conventional agrochemicals and biorationals, such as biocontrol agents, biostimulants, plant srengtheners, soil conditioners, plant aids and fertilisers for professional and amateur use.
Agrochemicals & Biorationals Overview
Our expertise is based on dozens of active substance registrations, hundreds of submitted and defended dossiers for agrochemical and biorational products.
For more than two decades, SCC has been offering a broad spectrum of regulatory and scientific services for biocides, including preparing, submitting and defending dossiers for biocidal active substances, products and product families.
Since 2000, we have submitted and defended over 20 active substance dossiers in nearly all PTs and numerous dossiers for biocidal products and product families.
Our experts offer full-scale regulatory and scientific services for chemicals on the European and international markets. We provide registration support for all types of chemical substances, such as mono- and multi-constituent substances, nano-materials and UVCBs, both inorganic and organic.
Since 2007, we have prepared 600+ lead dossiers for phase-in/non-phase-in substances, handled 50+ PPORD notifications, >1,000 CLP notifications.
Our services for medical devices include risk assessment according to ISO 14971, biological evaluation in line with ISO 10993, clinical evaluation and qualification and validation.
Medical Devices Overview
SCC supports you with fulfilling the requirements of MDR (EU) 2017/745, helping get your products fit for the market launch and keep your documentation up-to-date.
We can support you with PIF generation and review, label review, artwork clearance and claim substantiation. We prepare and submit CPNP notifications, evaluate and monitor safety assessments. We also help you develop SCCS safety dossiers for regulated cosmetic and other active ingredients.
We have prepared 60+ safety dossiers for a variety of challenging ingredients, offering full-scale regulatory support, including advice on alternatives to animal testing.
SCC provides scientific support for pharmaceuticals in the fields of non-clinic evaluation and environmental risk assessment as well as study monitoring and preparation of expert statements on toxicology or ecotoxicology, including environmental fate and behaviour.
SCC offers scientific and regulatory advice for pharmaceuticals, focusing primarily on non-clinical and environmental services.
For consumer products, our regulatory services include detailed data gap analysis, safety and risk assessments for exposure scenarios, advice for classification and labelling and preparation of safety reports / dossiers.
Consumer Products Overview
With vast knowledge of national and EU regulations and understanding of the industry's needs, we help you master all your registration challanges.
Food Contact Materials
Our experts navigate you through the FCM authorisation process in the EU, help you develop the registration strategy, write and submit complete registration dossiers, conduct safety assessments, carry out compliance checks and prepare DoC (Document of Compliance) in line with Regulation (EC) No. 1935/2004.
Food Contact Materials Overview
SCC pilots you through the hurdles of the FCM authorisation process, helping your products comply with the current regulatory requirements.
We offer a wide range of technical and regulatory consulting services designed to facilitate the authorisation process for feed additives, including establishment and management of quality systems, new application dossiers, development of waiving strategies and advice on GMO-related issues and toxicity concerns.
Feed Additives Overview
Since 2001, we have successfully submitted and defended over 50 re-authorisation dossiers for feed additives. Our experts help you make your additives fit for the EU market.