Fulfilling the recently updated regulations Companies that import APIs into the EU from non-white listed countries must present at customs a series of relevant documents.
We offer qualification services for suppliers and products, as well as documentation review before starting import procedures.
We offer consulting advice for importers and distributors of active substances for such registers as the Register of Manufacturers. Qualification and supplier audit even of non european countries. Importers and Distributors of Active Substances (´RUESA´ in Spanish)


We can advise you on the following quality items and Regulatory Affairs:

• Manufacturer documentation review. Manufacturer qualification.

• Audits of APIs manufacturers and Suppliers both nationally and internationally

• GMP Certification

• Written Confirmation

• Product documentation review

• Certificates of analysis

• Review of the DMF / ASMF and Expert Report of technical dossiers for drug registration

• Registration of Active Substance manufacturers, Importers and Distributors (RUESA)