WTC and its global network offer comprehensive chemicals notification/ registration services that comply with existing chemical regulatory schemes in major countries of the world.
Regulatory Affairs Services
We provide consulting on notification/ registration strategies and test programs, scientific and regulatory evaluation of test data, compilation and submission of registration dossier to regulatory authorities, as well as negotiations with regulatory agencies.
Safety Testing Services
Our safety testing services include conception, monitoring, and management of experimental studies (physical-chemical properties, eco-toxicity, toxicology, mutagenicity, analytic - as needed) at laboratories of our client's choice (CRO). The tests will be performed according to the relevant international test guidelines, e.g., OECD, METI, OPPTS, EC, etc. Under certain regulatory schemes, it is necessary to perform specific tests in an appropriate (accredited) laboratory located in the country of registration, as in the case of China.
Chemicals Registration in the European Union
We offer a wide range of regulatory affairs services for chemicals registration in the European Union. Our services include advice on registration strategy, collection, review, and evaluation of data available, literature search, and evaluation of data, gap analysis, recommendations for filling/handling data gaps, expert statements, bridging and waiving concepts, QSAR-modeling, conception, execution, and management of experimental studies with laboratories (CROs), robust summaries, data entry into IUCLID database, environmental exposure assessments, occupational and human exposure assessments, hazard assessment, classification and labeling, compilation of exposure scenarios, compilation of the registration dossier (IUCLID), compilation of the chemical safety report, compilation of extended safety data sheet (e-SDS), SIEF/ consortia management, third-party representative.
Under REACH, keeping registrations up-to date is a core responsibility of the registrant.
Current developments, such as changes under the REACH revision, the Chemicals Strategy for Sustainability (CSS), the restriction roadmap, the assessment for regulatory needs, etc. must be kept in mind. Possible deficiencies in the registration dossier must be identified. Neglecting these duties, often triggers requests for additional information by ECHA. Proactive handling of regulatory obligations supports business sustainability.
To support our clients' products and business sustainability, WTC offers tiered models:
Basic
Technical completeness check (TCC):
- TCC-Report to customer
- TCC: Elimination of errors
Professional
- TCC-Report to customer
- TCC: Elimination of errors
- Update dataset to latest IUCLID version
- Webmeeting as needed
- Submission to ECHA on customer request
Premium
- TCC-Report to customer
- TCC: Elimination of errors
- Update dataset to latest IUCLID version
- Current BoA Decisions
- Sustainable strategy: taking into account current and future developments
- Webmeetings as needed
- Submission to ECHA on customer request
- Advocacy (company/ consortium) activities
With our expertise and experience in chemicals registration and REACH compliance, we can help you navigate the regulatory landscape smoothly. Contact us today to learn more about our services.
