Hire Nitasha Pathak Joshi, a pharma consultant specializing in Analytical Testing, Clinical Studies and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Nitasha Pathak Joshi is a pharmaceutical regulatory affairs and analytical quality professional with experience across regulatory filing, analytical development, method validation review, stability studies, quality control, and compliance audits. Her background includes work with the Indian Pharmacopoeia Commission, Unichem Laboratories, and Ankur Drugs and Pharma, alongside responsibilities in pharmaceutical regulatory affairs. She supports regulatory applications, licensing documentation, and coordination with CDSCO and State FDA authorities. Her analytical experience includes reference standard development, drug testing, instrument calibration, and review of analytical and CMC documentation. She has also delivered practical drug-testing training to personnel from central and state laboratories. Combining laboratory and regulatory experience, she helps organizations strengthen submission documentation, testing practices, and compliance records. - Show More
Nitasha supports analytical development through experience developing pharmaceutical reference standards and performing characterization, homogeneity, and stability assessments. Her background includes analytical R&D documentation and drug analysis using chromatographic, spectroscopic, and thermal techniques. She helps laboratories generate and organize analytical evidence supporting reference materials and pharmaceutical testing activities.
Nitasha supports CMC documentation review through experience assessing drug master files, analytical documents, and regulatory dossier modules. Her background includes reviewing documentation associated with IND and ANDA filings. She helps teams assess the completeness and consistency of analytical and quality information and organize supporting records for regulatory submission activities.
Nitasha supports pharmaceutical GMP audits through experience leading MHRA and WHO audit activities and conducting quality compliance reviews. Her work also includes internal audit support, inspection documentation, and tracking corrective actions. She helps teams assess procedures and supporting records, identify compliance gaps, and coordinate follow-up on audit observations.
Nitasha supports analytical method validation review through experience assessing validation documents and related analytical records at the Indian Pharmacopoeia Commission. Her laboratory background includes HPLC, LC-MS, GC, UV, and other analytical techniques. She helps teams review validation documentation, identify gaps in supporting information, and maintain clear records for quality and regulatory purposes.
Nitasha supports pharmaceutical quality control through experience testing raw materials, finished products, and cephalosporin products. Her background includes HPLC, dissolution, Karl Fischer titration, and other analytical techniques, alongside instrument operation, maintenance, and calibration. She helps laboratories strengthen SOP adherence, analytical reporting, and documentation practices, and provides practical training in drug testing.
Nitasha supports pharmaceutical regulatory applications, licensing documentation, and coordination with CDSCO and State FDA authorities. Her experience includes export NOCs, import-related applications, product permissions, manufacturing licenses, and CoPP documentation through platforms such as Sugam, NSWS, and ONDLS. She helps teams prepare supporting records, track submissions, and coordinate responses to regulatory requirements.
Nitasha supports stability programs through experience in pharmaceutical product stability analysis and stability assessments for reference materials and proficiency testing items. Her work includes maintaining analytical documentation and preparing reports. She helps laboratories organize study records, review supporting results, and document stability activities in accordance with established procedures.
