Hire Khyathi Wardhan, a pharma consultant specializing in Anlaytical Testing, FDA Inspections, Medical Devices and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Asia, Europe, North America
Consultant Type: Independent Consultant
Expertise summary: Khyathi Wardhan is a CMC and quality-focused pharma consultant supporting analytical development, GMP compliance, and inspection readiness for small molecules and complex products. She helps teams build practical, submission-ready workflows with strong documentation, data integrity, and risk-based decision-making. She is known for simplifying complex compliance and CMC requirements into clear, executable SOPs and study plans. Her work reduces audit risk, accelerates method transfer, and improves cross-functional alignment between QA, QC, and manufacturing teams.
Khyathi supports end-to-end analytical method development for drug substances and drug products, ensuring methods are fit-for-purpose from early development through commercial QC. She helps design stability-indicating assays, impurity methods, and supporting tests with strong robustness, reproducibility, and documentation. Her expertise includes method optimization, troubleshooting (co-elution, carryover, variability), and building validation-ready packages aligned with ICH and GMP expectations. She also supports method transfer to CRO/CMO/QC labs, reducing transfer failures through clear protocols, system suitability criteria, and training-ready SOPs that stand up during audits and inspections.
Khyathi designs dissolution strategies that are clinically meaningful, discriminatory, and regulatory-ready for IR/MR oral dosage forms. She supports method selection (apparatus, media, rpm, sampling), comparative dissolution (f2) for bridging, and specification setting with scientific rationale. When dissolution failures occur, she leads structured investigations to identify root causes across formulation, raw materials, compression/coating, and analytical factors, with compliant documentation. She also supports dissolution method transfer between labs, minimizes variability through execution controls, and helps teams build dissolution programs that protect product performance and reduce post-approval risk.
Khyathi prepares teams for FDA inspections through targeted gap assessments, mock audits, and inspection-room coaching. She strengthens core quality systems—deviations, CAPA, change control, validation, training, supplier quality, and laboratory controls—so evidence of compliance is clear and consistent. A major focus is data integrity: ALCOA+ behaviors, audit-trail awareness, documentation discipline, and investigation quality. She helps teams organize documents, respond confidently to investigator requests, and eliminate high-risk gaps before inspections. The result is reduced observation risk and a more resilient, inspection-ready culture.
Khyathi builds practical GMP compliance systems that reduce repeat issues and improve audit outcomes. She supports implementation and improvement of deviations, investigations, CAPA effectiveness, change control rigor, validation lifecycle thinking, training systems, and laboratory compliance. She helps teams identify true root causes, close gaps sustainably, and align daily execution with GDP and data integrity expectations. Her work often bridges QA, QC, and operations to remove interface failures that trigger recurring observations. The outcome is stronger operational discipline, cleaner documentation, fewer compliance surprises, and a quality culture that can scale with growth.
Khyathi is a skilled pharmaceutical scientist specializing in analytical method validation and development, with hands-on experience across a broad range of dosage forms and analytical platforms. She has successfully led validation projects ensuring compliance with global regulatory requirements including ICH, USP, and FDA guidelines. Her technical strength lies in designing robust validation protocols, interpreting complex analytical data, and troubleshooting method performance issues to achieve reproducible and reliable results. As an independent consultant, Khyathi now supports pharmaceutical companies in optimizing their analytical strategies, accelerating regulatory submissions, and ensuring the highest standards of data integrity and compliance.
Khyathi supports PMA-aligned technical documentation by improving traceability, consistency, and review-readiness across CMC and quality sections. She helps teams organize evidence so that specifications, methods, validation data, stability rationale, and risk controls align cleanly and are easy to verify. This includes strengthening technical summaries, resolving contradictions between documents, and ensuring supporting data is complete and well-referenced. Her approach reduces review friction by presenting clear scientific justifications and submission-ready narratives—especially valuable when multiple sites or vendors contribute data and the submission needs tight integration and strong document control.
