Saikrishna Thirdhala

About Saikrishna Thirdhala

Regulatory Affairs Specialist | API & Pellets | Global DMF Submissions | Compliance & Documentation ExpertAccomplished and detail-driven Regulatory Affairs professional with extensive experience in API and Pellets, specializing in global regulatory submissions, lifecycle management, and cross-functional documentation review. Proven ability to navigate complex regulatory landscapes and ensure compliance across international markets.Core Competencies:NDC SubmissionsGlobal DMF Lifecycle ManagementExpert in the compilation, review, and submission of Drug Master Files (DMFs), including original submissions, amendments, annual reports, and updates for USDMF, CEP, KDMF, EU ASMF, Taiwan DMF, CDMF, and other global regulatory frameworks. Proficient in managing new filings, renewals, variations, and revisions, ensuring alignment with evolving regulatory standards.Regulatory Communication & Query HandlingExperienced in drafting high-quality responses to customer and agency queries, including:US FDA (Incomplete response and complete response)EDQM (deficiencies like additional information and request for clarification)EU ASMF (Day-70, Day-90, Day-120, Day-180, Day-210 queries under National procedure, Centralized procedure, Mutual Recognition procedure and Decentralized procedure), China and Egypt Drug Authority queriesEnsures clear, accurate, and timely communication to support regulatory approvals.Cross-Functional Document ReviewAdept at reviewing QA/QC, R&D, and AR & D documentation to ensure regulatory compliance and readiness for submission. Collaborates effectively with internal teams to align technical content with regulatory expectations.Regulatory Documentation & Authorization SupportSkilled in preparing and issuing Letters of Authorization (LOAs), Letter of Access (LOC) Letters of Commitment (LOCs), No Change Declarations, and Certificates of Pharmaceutical Product (COPPs) as per customer and agency requirements and handling tools like Pharma ready, Knowledge ectd, Lorenz evalidator, Next Gen eCTD, Chemdraw and ChemsketchWith a strong commitment to regulatory excellence, I bring a proactive, collaborative, and compliance-focused approach to supporting global product registrations and lifecycle management.Let’s connect to explore in regulatory affairs, pharmaceutical compliance, and international market authorizations.

Experience

1. Senior Executive

   HRV Pharma

   May 2025 — Present · Hyderabad, IN