He is an expert in Clinical development as well as manufacturing of experimental pharmaceutical drug products.  Additionally, he is an expert in Scaling-Up or Large-Scale Commercial manufacturing and marketing of pharmaceuticals drug products intended for human consumption.

When it comes to formulating, writing and implementing Remedial and Enhancement Regulatory Compliance programs, He deems this to be his forte. In light of this, he also has a wide-spread working awareness and direct work experience in the following:

a)    Current, Good Manufacturing Practices (cGMP)
b)    Good Laboratory Practice (GLP)
c)    Good Clinical Practice (GCP)
d)    International Conference on Harmonization (ICH)

He is an accomplished Regulatory Affairs professional who was able to enhance his skills in the most basic and traditional way – by starting from the bottom and then working his way up to the
trenches of the pharmaceutical industry.

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