Provides expert regulatory advice to pharma companies for domestic and global submissions. Assists clients in preparing CTD, ACTD, and Common Technical Dossiers. Guides clients through new drug application, ANDA, and biosimilar filings. Reviews dossiers for regulatory gaps and prepares deficiency response support. Provides regulatory intelligence on CDSCO, FDA, EMA, and WHO guidelines. Conducts regulatory training workshops for pharma R&D and QA teams. Supports pre-submission meetings with CDSCO and regulatory authority interactions. Reviews labeling, package inserts, and patient information leaflets for compliance. Assists with regulatory strategies for product lifecycle management. Supports regulatory due diligence for pharma M&A and licensing transactions. Prepares regulatory gap assessments for GMP upgrades and new facility certifications. Manages post-approval variation and renewal filing strategies for clients. Stays current with CDSCO policy updates, ICH guidelines, and global regulatory changes.