SCC Scientific Consulting Company Japan List of Products and Services

Our company ensures compliance with ISO 13485, MDR 2017/745, other QMS standards, and legal requirements in various countries through practical expertise in quality management, providing comprehensive support. Creation and maintenance of the Quality Management Manual (QMM). Formulation of quality policies, including quality plans and quality objectives, and identification of key performance indicators that enable objective process evaluation. [Overview of Quality Management Services] ■ Gap analysis and standards investigation ■ Practical support in process optimization, monitoring, and documentation ■ Guidance on EUDAMED (European Medical Device Database) *For more details, please refer to the PDF materials or feel free to contact us.

• Other services

We provide services for medical device manufacturers. We support our clients with various services necessary for medical device approval. For example, we offer services such as quality management, risk management, biological evaluation, specialized literature searches, and clinical evaluations. Our company is a strong partner that addresses various scientific and regulatory needs. 【Service Overview (Partial)】 ■ Comprehensive consulting services and strategies for entering international markets ■ Internationally approved quality management systems ■ Addressing the impact of medical devices on human health and the environment ■ Specialized literature search and provision services for clinical evaluations and other needs ■ Qualification confirmation and validation of manufacturing and quality management equipment and methods *For more details, please refer to the PDF document or feel free to contact us.

• Other services

We would like to introduce "KKDIK - Turkey REACH." KKDIK is Turkey's new chemical substance regulation that aligns with the EU's REACH regulations. Our company collaborates with well-known partners in Turkey to address all your needs regarding the registration of chemicals and biocides, as well as chemical regulation. From developing regulatory compliance strategies to arranging and monitoring safety tests, and providing OR services through local partners, you can trust us with your needs. 【Service Contents】 ■ Development of regulatory compliance strategies ■ Arrangement and monitoring of safety tests ■ OR services by local partners ■ Preliminary registration ■ Main registration (from January 1, 2021) ■ Follow-up * You can download the English version of the catalog. * For more details, please refer to the PDF materials or feel free to contact us.

• Other contract services

We would like to introduce "UK REACH." Companies from Japan, the UK, EU-27, and other regions that manufacture or sell chemical substances in the UK in quantities exceeding 1 ton per year, whether as individual substances or mixtures, are required to register those substances under UK REACH. Our company offers registration support, as well as assistance in obtaining data from EU REACH through our legal department, SCC Legal. For more details, please contact us. 【Services for companies outside the UK (EU-27, Japan, etc.)】 ■ Agent services through our local subsidiary ■ Registration support (from January 1, 2021) ■ Assistance in obtaining data from EU REACH through our legal department, SCC Legal ■ Development of regulatory compliance strategies, including testing policies, for registration in the UK * You can download the English version of the catalog. * For more information, please refer to the PDF materials or feel free to contact us.

• Other contract services

Our company handles "Chemical Management." A directive to amend the EU Waste Framework Directive was published on May 30, 2018. As of January 5, 2021, and thereafter, companies supplying molded products to the EU market must provide information to the EU SCIP database for molded products containing substances of very high concern (SVHC) in concentrations exceeding 0.1 weight%. If you need to improve regulatory compliance or secure your supply chain in Europe, please feel free to contact us. 【How to Submit SCIP Notifications (Submission in 3 Steps)】 1. Collect information on SVHCs in molded products. 2. Edit all SVHC information for SCIP notification in IUCLID format. 3. Submit the SCIP notification to the ECHA submission portal. *You can download the English version of the catalog. *For more details, please refer to the PDF materials or feel free to contact us.

• Other contract services

Our company accurately captures our customers' needs regarding chemical regulations in major countries around the world and provides support for "chemical management" based on our extensive experience and knowledge. After receiving the necessary information from our customers for notification, we will carry out submissions via the ECHA Submission portal and assign product categories using the European Product Categorisation System (EuPCS). If you are looking to enhance business flexibility in Europe and secure your supply chain, please feel free to contact us. 【Our Services】 ■ Acquisition of Unique Formula Identifier (UFI) ■ Creation of Poison Centres Notification (PCN) dossier ■ Submission via ECHA Submission portal ■ Assignment of product categories using the European Product Categorisation System (EuPCS) *You can download the English version of the catalog. *For more details, please refer to the PDF materials or feel free to contact us.

• Other contract services

Our company provides support to customers worldwide in response to the need for regulatory and scientific assistance across various fields. In the chemical sector, we maintain a broad network with European authorities (ECHA and national regulatory bodies), international organizations, and industry associations, and are widely recognized as a reliable and competent partner. We leverage our years of expertise in global registration strategies and services, dossier preparation and submission, cost-effective testing solutions, and consortium management. [Achievements] ■ Over 600 lead dossiers and new substance dossiers submitted, including OR services for Japanese companies under REACH ■ Management of 30 consortia and similar operations ■ Support for compliance with regulations in Asian, North American, and Oceanian markets ■ Initiated REACH registration support in Japan since 2007 ■ Proposal of testing packages at reasonable values ■ Strength in risk assessment for human health and the environment using exposure models for humans and the environment *For more details, please download the PDF or feel free to contact us.

• Management consultant/Small business consultant