Compile NDA / ANDA submissions. Conduct PAI audits. Commission facilities to be in compliance with GMP.\Evaluation and analysis of FDA #483 observations and response letters. Design and evaluate Process Validation Protocols & Reports. Establish an IQ/OQ/PQ system. Design and Prepare Technical and Product Development Reports. Customize SOP manuals and other Documentations. Audit contract laboratories & manufacturers and R.M. vendor certification. General assessment for Regulatory Compliance. Drug Master File preparation.