REGULATORY

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

Services:

Data GAP Analysis

EU dossier (Annex III) preparation according to OECD format

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

Biological assessment dossier (BAD)

Study monitoring

Representing client company with Spanish authorities (including visits)

Dossier follow-up & updating autorisations:

  • New uses
  • Change of composition
  • Change of toxicological clasification
  • Change in PHI
  • Changes in holder, manufacturer
  • Change in name
  • Others

Equivalence of technical materials of substances

Mutual recognitions

MAIN OFFICE SPAIN

SynTech Research Spain

Camino los Huertos s/n
(46210) Picanya
Valencia

Phone: +34 961 759 050
Mobile: +34 619 138 505
info@syntechresearch.es

MAIN OFFICE PORTUGAL

SynTech Research Portugal

Rua António Oliveira, 21
Freguesia de Santo Onofre
2500-916 Caldas da Rainha

Phone: +35 (1) 939 226 869
Mobile: +34 638 061 053
flopez@syntechresearch.com