Radha Krishna Reddy Ph.D

Amassed nearly 19 years of progressive experience spanning Analytical Research & Development (R&D), Quality Control (QC) in API and Formulation, and Regulatory Compliance, bringing a unique blend of technical depth, operational leadership, and regulatory expertise. Recognized for driving innovation in analytical sciences, developing, validating, and transferring novel analytical methods for Assay, Impurities, Nitrosamine Impurities, Dissolution, Residual Solvents, and PSD Methods, ensuring regulatory-ready data packages and smooth technology transfers. Hands-on expertise across a suite of advanced techniques: HPLC, UPLC, GC, Dissolution, UV-Vis, FTIR, PSD, LC-MS, HRMS, GC-MS, DSC, and XRD, applying them to resolve challenging scientific, regulatory, and manufacturing problems. Hands-on experience across Solid orals, Liquid orals, Semi-solids, Injectables, Medicinal devices, Female hormones and Active pharmaceuticals. Skilled in end-to-end project ownership, from conceptualizing analytical strategies to executing ANDA submissions, managing site/ technology transfers, conducting comparative dissolution studies, and supporting global regulatory filings (USFDA, EMA, MHRA, HC, TGA, WHO, and other major markets). Strategic thinker with expertise in designing fit-for-purpose analytical systems and compliance frameworks that align GLP, GMP, GDP, 21 CFR Part 11, and data integrity standards, resulting in audit readiness and zero-observation outcomes. Proven ability to translate complex data sets into actionable insights, supporting decisions in drug development, lifecycle management, impurity qualification, risk assessment while safeguarding product quality and patient safety. People-oriented leader with skills in building, mentoring, and scaling high-performing teams of ~60 scientists by introducing structured training programs, competency-building frameworks, and culture of accountability.

• Method Development, Validation & Transfer: Assay, Related Substances, Residual Solvents, Dissolution, Content Uniformity, Cleaning Methods, and other analytical techniques.
• Specifications & Test Procedures: Design, review, and approval of specifications and STPs for APIs, Excipients, and Finished Products.
• Impurities Analysis:
• O Nitrosamine & NDSRI Impurities – Method development, validation, and decision-making for routine testing.
• O Genotoxic Impurities – Development, validation, and decision-making for routine testing.
• O Elemental Impurities – Method development, validation, and batch analysis.
• O Qualification of Impurities beyond ICH/FDA/EMA thresholds via toxicological studies, QSAR/In-silico, Enhanced Ames Test (EAT).
• Dissolution & Solubility Studies: Multimedia Dissolution (MMD), Comparative Dissolution Profiles (CDP), BCS Solubility for biowaivers.
• Cleaning Method Validation: Swab analysis, recovery studies, and validation for product contact and non-contact surfaces.
• Regulatory Submissions & Projects: ANDA, Technology Transfers (TT), Stability Testing (ST), Source Addition Projects, and DMFs.
• Vendor Qualification: For APIs, Excipients, and Packaging Materials.
• Deviation Management: Strong expertise in OOS/OOT investigations and root cause analysis.
• Analytical Instrument Qualification: New installations and retrospective qualification of existing instruments.
• Regulatory Query Handling: Responding to USFDA, EMA, MHRA, HC, TGA, WHO, China, Mexico, Brazil, and ROW authorities.
• Product Range Experience: Hands-on exposure to OSD, Medical Devices, Ointments, Creams, Injectable, and Renal Products.
• Compliance & Quality: Strong knowledge of Data Integrity, GLP/GMP, 21 CFR Part 11, Safety & Compliance.