Kruti Desai Email and Phone Number

Store #1154

Achieved 1st rank among 55+ professionals in a 3 Month-long intensive training program on Analytical Pharmacy, Quality Assurance, Quality Control, Hands-on training on Analytical Instruments, Regulatory aspects in Pharma and Wet chemistry.> Various domestic applications: CT, BE, CDTL, manufacturing and marketing, query replies, NCE application, etc.> Project evaluation as per the DCGI checklist for document requirement and accordingly request of documents to the concerned departments.> Preparation of covering letter, form-44, rationale, a summary of drug-drug interactions, a summary of pharmacological and toxicological data, brief chemical and pharmaceutical data for FDC applications, adequate evidence of concomitant administration for FDCs; Evaluation of documents; Final compilation of application.> NDAC presentation: Preparation of executive summary for NDAC referral as well as 11 sets of NDAC dossier. Compilation of documents required for NDAC presentation e.g., the sequence of events, application supporting, etc.> Literature search: Extensive literature search for domestic application [for the new drug, new dosage form, FDC, new indication]; Search for post-marketing studies for DCGI approved molecules; search for dietary products.> Preparation of Schedule Y applications: adding data related to phase I, phase II, phase III, post-marketing, formulation data, API data, etc.> Preparation of e-CTD application for subsequent new drugs.

The training was basically a part of the Masters Program, conducted at the CRO-Cadila Pharma (BA-BE studies). It primarily included QC of the documents along with study coordination and monitoring. Protocol writing, ICF obtainment, ICU auditing were also inclusive of the endeavor.