SynTech Research Spain

SynTech Research SpainRegulatory Affairs

SynTech Research Spain

Regulatory Affairs

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

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.

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 formatCORE DOSSIERFOR EACH MEMBER STATE

Biological assessment dossier (BADBAD) Study monitoring Representing client company with Spanish authorities

(including visits) Dossier follow-up Equivalence of technical materials of substances Mutual recognitions

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

SynTech Research Spain

Regulatory Affairs• At Member State level we offer:√ Updating authorisations:

New usesChange of compositionChange of toxicological clasificationChange in PHIChanges in holder, manufacturerChange in nameOthers

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

SynTech Research Spain

Regulatory Affairs

Preparation, submission and follow up of dossiers

SIEF participation or follow-up

SynTech Research Spain

Regulatory Affairs

SynTech Research Spain

SynTech Research SpainRegulatory Affairs