Pharma
REACH (Registration, Evaluation, Authorization of chemicals)
SERVICES
Training for the correct interpretation of REACH
- Training of companies to prepare staff to correct interpretation and application of REACH
Audit c/o companies interested to REACH
- Inventory of chemical substances and analysis of the supply chain
- Role and obligations assessing within REACH
- Correct identification of substances
Pre-registration procedures
- Handling of activities under IUCLID 5 for pre-registration
- Advising in pre-registration of phase-in substances
Management of registration
- Inventory of available data
- Definition of the best testing strategy
- Data gap analysis (physico-chemical, ecotoxicological and toxicologic studies)
- Compilation of IUCLID 5
- Management of relationship with competent authorities
- SIEF and consortia management
Preparation of dossiers and of CS
- Preparation and handling of dossier for Registration
- Definition of use and of Exposure Scenarios
- Elaboration of chemical safety assessments (CSA) and of chemical safety reports (CSR)
Analytical services
- Spectral data and other tests for identification aqnd/or characterization of substances (Annex VI Section 2)
- Physical-chemical tests according to annex VII and IX
- Toxicological studies in GLP according to annex VII-X
- Ecotoxicological studies in GLP according to annex VII-X
- Test for identification and quantification of substances and impurities (UVCB characterization, SVHC quantification in articles, monomers in polymers, etc.)
Safety data sheets (SDS) - Classification and labelling
- Classification and labelling (C&L) of substances and prepatates (Reg. GHS Globally Harmonized system)
Preparation of extended safety data sheets (eSDS).
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