Regulatory Submission Documents

IND/NDA and International Equivalents

Compile Drug Master Files(DMFs)

IDE/510(k)/PMA and International Equivalents

Prepare nonclinical section of submission documents 

          Prepare CMC section of submission documents

          Prepare Labeling section of submission documents

            Compile and submit amendments and variations to clinical and commercial license

                      Respond to Requests for Supplemental Information during regulatory reviews  

Review of promotional materials

Establishment of regulatory SOPs