Regulatory Documentation / Approvals

We offer the following documentation for our products:

Pharmaceutical Grade Products

(Manufactured according to ICH's cGMP Guide for API (Q7))

- Letter of Access to Certificates of Suitability (Ph.Eur. grades)
- Declaration of cGMP manufacture signed by local authorities
- Certificate of analysis
- Datasheet
- MSDS
- Declaration of DS/EN ISO 9001 certificate
- Declaration of DS/EN ISO 14001 certificate

We work as well in close cooperation with our Pharmaceutical Grade customers to provide the necessary regulatory documents, such as:

- Impurity profile
- Short description of method of analysis
- Description of the manufacturing process
- Simple process flowchart
- Packaging details
- Answering of questionnaires
- Preparation of a full Drug Master File (DMF for USP/NF, BP grades)
- Customer audits of FeF Chemicals' plant can be arranged