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SynTech Research Spain Regulatory Affairs

SynTech Research Spain Regulatory Affairs. Plant protection products. Biocides. Plant nutrition. REACH. Regulatory Affairs.

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SynTech Research Spain Regulatory Affairs

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  1. SynTech Research SpainRegulatory Affairs Plant protection products Biocides Plant nutrition REACH SynTech Research Spain

  2. Regulatory Affairs • SynTech Research Spain is an independent consultancy providing advice and support for regulatory affairs, preparing & managing submissions at a National and European level. SynTech Research Spain

  3. Regulatory Affairs • The regulatory department is led by Ms. Pepita Duran, with 14 years of experience in the agrochemical industry, allowing us to handle succesfully your projects. SynTech Research Spain

  4. Regulatory Affairs • Types of Service: • Data GAP Analysis • EU dossier (Annex III) preparation (91/414/EEC, 98/8/EC) according to OECD format • CORE DOSSIER • FOR EACH MEMBER STATE • Biological assessment dossier (BAD) • Study monitoring • Representing client company with Spanish authorities (including visits) • Dossier follow-up • Equivalence of technical materials of substances • Mutual recognitions SynTech Research Spain

  5. Regulatory Affairs • Annex III dossier preparation: • Total Annex III or just sections needed by the client • MSDS • Documents L, M, N, others • TOXICITY • Operator (German & UK model), by-stander, worker exposure calculations • HEALTH CONSUMERS • TMDI & NEDI calculations • ENVIRONMENTAL • PEC calculations (PECgw: MACRO, PELMO, PEARL & PECsw (FOCUS steps 1/2/3/4), PECs • ECOTOXICOLOGY: risk assessment • TERs (exposure/toxicity), HQ • BAD • Technical translations SynTech Research Spain

  6. Regulatory Affairs • At Member State level we offer: • Updating authorisations: • New uses • Change of composition • Change of toxicological clasification • Change in PHI • Changes in holder, manufacturer • Change in name • Others SynTech Research Spain

  7. Regulatory Affairs • Study Commissioning / Monitoring: • After the Data GAP Analysis advise on new tests (field & lab) needed is provided. • Monitoring of Studies offered if needed SynTech Research Spain

  8. Regulatory Affairs REACH • Preparation, submission and follow up of dossiers • SIEF participation or follow-up SynTech Research Spain

  9. Regulatory Affairs CONFIDENTIALITY SynTech Research Spain

  10. SynTech Research SpainRegulatory Affairs Plant protection products Biocides Plant nutrition REACH SynTech Research Spain

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