Fish oil

CAS number
Biological
Application
Fish oil comes from many types of fish. It is rich in two important omega-3 fatty acids called eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Routes
Oral

SOCOSUR PDE monographs are a quick and efficient way to obtain:

  • Risks identification
  • Identification of potential critical effects
  • Rationale for NOAEL values selection
  • Complete description of adjustment factors F1 to F5 as well as PK correction
  • Complete review of all relevant pharmaceutical and medical databases, public or private, European or not in accordance with EMA guideline EMA/CHMP/CVMP/SWP/169430/2012, signed by an European toxicological expert with full CV

Benefits of such PDE monograph

A 16 to 25 pages report optimized in case of Regulatory Body inspection with all calculation details and all bibliographic references linked to these calculations.

How to initiate a quotation request and a supplier qualification within your quality system?