Projects
Create a vision, articulate the vision, passionately own the vision, and relentlessly drive it to completion.
IND Submission
Created an eCTD compliant IND submission template for the combination product Inbrija
NDA Submission
Built an NDA submission model for Inbrija, listing and explaining all CTD modules with detailed information about all sub – sections
Regulatory Startegy
Submitted a regulatory business strategy for launching biopsy needle for US, EU, Canada, Mexico, China and Australia
Warning Letter
Drafted a warning letter to address Corrective Action and Preventive Actions for adulterated EYE-SYNC medical device
IDE Template
Generated a template on IDE for Atrial Fibrillator listing all necessary safety related guidance for pre-market for EU and US
Informed Consent Form
Drafted a 21 CFR 50 compliant Informed Consent Form for Donepezil HCl for Alzheimer’s Disease with multi- center, open-label, single-arm, prospective, phase III trial
Pre-Market Safety
Composed a research paper on safety study information (pre-market) explaining ICH E2A, E2B(R3) and E6 along with ICH M3(R2), 21 CFR 320 and 321 giving examples from Inbrija like clinical pharmacological and safety and efficacy study data
Post-Market Safety
Devised a PBRER/PSUR template for post market requirements for Inbrija for the US and EU with E2C(R2) and E2D, EU Regulation 726/2004, GVP Module VII and REMS Module V
Off-Label Promotion
Wrote a research paper on Off-Label Promotion of an approved drug, Mifepristone, in accordance with 21 CFR 202 and 352
Drug Package Insert
Researched how a package label is designed and relevant guidance for drug label as per 21 CFR 201
Clinical Protocol
Composed a Clinical Protocol, A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo- Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects with early Parkinson’s Disease