1. USDMF Administrative and Technical amendments2. CMC Responses to USFDA deficiency letters3. CEP Renewal, Revision and Responses4. Canada Biannual Updates5. Australia DMFs and responses to TGA Queries6. Korea DMF Registration7. Emerging (ROW) Markets Applicants part DMF and Technical packages submissions8. Assess Change Controls through Track Wise and analyze its regulatory impact9. Knowledge in DCM and CITRIX of eCTD submissions10.NeeS Submissions of ASMF and its requirements.

1. USDMF Original Submissions2. USDMF annual reports and amendments3. Japanese Master File (JDMF) original submissions4. Submissions of Minor change notifications to PMDA through ICC agent (Japan).5. Done renewal of accreditation of foreign drug manufacturers (AFM)6. Knowledge on Sterile APIs and Type V DMFs. 7. Knowledge on Sterile Processing Details of Manufacturing facilities and its requirements.8. Handling Change controls and analyzes its regulatory impact.9. ROW applicants part of DMF and TIP submissions.10.Handled submission of responses to emerging markets authorities such as ANVISA, SFDA(Saudi).11. Submitted eCTD of USDMF amendments and annual reports through Lorenz Docubridge.