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SynTech Research Spain SynTech Research Spain Regulatory Affairs.

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Presentation on theme: "SynTech Research Spain SynTech Research Spain Regulatory Affairs."— Presentation transcript:

1 SynTech Research Spain SynTech Research Spain Regulatory Affairs

2 SynTech Research Spain Regulatory Affairs advice support 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.

3 SynTech Research Spain 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.

4 SynTech Research Spain 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 BAD  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

5 SynTech Research Spain 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

6 SynTech Research Spain 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

7 SynTech Research Spain 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

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

9 SynTech Research Spain Regulatory Affairs

10 SynTech Research Spain SynTech Research Spain Regulatory Affairs

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