1 Notarized E-Copy Affidavit & Letter of Application 1-3

2 Valid License to Operate 4-5

Authenticated Letter of Authorization / Authenticated Agreement

3 Letter
6-11

Authenticated Certificate of Free Sale and Foreign Government /

4 Authenticate ISO Certificate
12-20

5 Indication & Directions for Use 21-25

6 List of Amount & Technical Specifications of all Raw Materials 26-31

7 Manufacturing Process & Declaration of Non Sterility 32-40

8 Finished Product Specifications 41-54

9 Biocompatibily Studies 55-89

10 Risk Management Analysis with FMEA / MSDS 90-134

11 Stability Studies 135-139

Primary & Secondary Packaging Specification / Labeling

12 Materials/Product Photo/Representative Sample
140-149