A- RAW MATERIAL AND EXTRACT ANALYSES

Product Documentation
Euromed can provide all the data required for registration of your product, from starting raw material ( for example, Good Agricultural Practices ) to the finished drug or soft extract. We also offer Drug Master Files, open and restricted parts, in the CTD format.

Manufacturing Process Validationy
Euromed can carry out the validarion of a manufacturing process, compiling complete documentation. This ensures the reproducibility, and the quality, of all pharmaceutical parameters such as extraction temperature, extraction time, and means of drying.

Validated Analytical Methods
Euromed can supply validated analytical methods (HPLC, GC, HPTLC, or UV-vis), using the same test method for source raw material, extract, and also your finished product. This provides the "red-line" documentation as currently required by many country´s Natural Health Product Departaments. The reference substances used in the analytical test are produced, and fully documented, in EUROMED´s state-of-the-art laboratory (see separete brochure).

Stability Test
A Stability testing of natural extracts at EUROMED is performed according to ICH guidelines.

Analytical Test
Potential contaminants such as heavy metals, aflatoxins, ochratoxins, pesticide residues, dioxins, PAHs, particularly Benz(A)pyren are tests for potential contaminants are done by an established control laboratory that is regularly audited.