---
title: 006
description: A consultant with The FDA Group.
---

[The FDA Group's Consultant Finder ](https://www.thefdagroup.com/find-consultants)

# [006](https://www.thefdagroup.com/find-consultants/006)

 Written by [The FDA Group](https://www.thefdagroup.com/find-consultants/author/the-fda-group) | Mar 10, 2022 4:19:44 PM

**Key Areas of Expertise**

- Regulatory Submissions (NDA, ANDA, DMF)
- CMC and Labeling Submissions
- Data Integrity and Quality Compliance Audits
- FDA Communication and Regulatory Strategy
- eCTD Submissions and Post-Approval Changes
- Project Management and Process Improvement

**Professional Experience**

*Consultant* – Global Pharma Consultants, LLC / Senior Manager, Regulatory Affairs - Professional Disposables International, Inc. (PDI)  
Various Locations | 2015-Present

- Conducts quality and data integrity audits for client companies in compliance with FDA ALCOA principles, supporting data accuracy and compliance for critical regulatory filings.
- Provides regulatory strategy and prepares submissions, including CMC sections for DMFs, NDAs, and ANDAs.
- Acts as primary FDA contact for clients, managing all communications, coordinating pre-IND meetings, and advising on regulatory strategy for products in pharmaceutical, OTC, medical device, and cosmetic categories.
- Drafted CTD modules, managed post-approval supplements, and coordinated IND submissions and amendments.

*Manager/Senior Manager, Regulatory Affairs* – Professional Disposables International, Inc. (PDI) / Nice-Pak Products  
Orangeburg, NY | 2012-2015

- Managed Regulatory Affairs team overseeing Pharma, OTC, medical device, and cosmetic products, including responsibilities for NDA, OTC drug, and 510(k) medical device submissions.
- Supported product compliance, including label supplements, IND submissions, NDA Annual Reports, and stability program implementation in compliance with ICH guidelines.
- Led quality team initiatives, filed an sNDA for new claims, and submitted PDI’s first 510(k) premarket notification, estimated to increase sales by $20 million.
- Spearheaded the creation of regulatory databases, including Master Lists and ingredient and claims databases, to improve process efficiency.

*Senior Regulatory Analyst* – Roxane Laboratories, Inc.  
Columbus, OH | 2007-2012

- Managed, authored, and filed approximately 20 ANDAs, multiple supplements, and annual reports, leading efforts for all international third-party projects.
- Provided regulatory guidance for products from development through approval, managed CMC deficiency meetings, and supported new product launches.
- Led initiatives to implement eCTD submissions and regulatory documentation, resulting in cost and time efficiencies.

*Chemist, QC Launch* – Boehringer-Ingelheim Roxane, Inc.  
Columbus, OH | 2003-2007

- Led analytical transfer projects, supporting nasal and solid powder inhalation products. Conducted gap analyses and implemented right-first-time initiatives, ensuring accuracy in testing.

*Scientist, Analytical Development Laboratory, R&D* – Torrent Pharmaceutical Ltd.  
Ahmedabad, India | 1994-1996

- Supported testing for development lots in Formulation Development, gaining expertise in HPLC, GC, FTIR, and other laboratory techniques across various dosage forms.

**Education**  
Master’s in Chemistry  
Banaras Hindu University, India

Honors Diploma in Systems Management  
NIIT, India

**Certifications and Training**

- Project Management Certificate – Xavier University of Cincinnati
- Basic Drug Development Certificate – Temple University
- Management Level Coaching – BI/Roxane Laboratories

**Professional Accomplishments**

- Filed over 20 ANDAs and more than 50 annual reports, including in eCTD format.
- Developed regulatory strategies that facilitated first FDA approvals for internationally developed products.
- Supported and launched over 20 generic products, managed large-scale international projects, and implemented significant process improvements in change management and documentation.

**Skills**

- Proficient in Microsoft Office, Trackwise, Documentum, and eCTD submissions.
- Strong communication, negotiation, and project management abilities.

[View full post](https://www.thefdagroup.com/find-consultants/006)

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