---
title: 016
description: A consultant with The FDA Group.
---

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

# [016](https://www.thefdagroup.com/find-consultants/016)

 Written by [The FDA Group](https://www.thefdagroup.com/find-consultants/author/the-fda-group) | Jul 11, 2022 5:42:07 PM

**PROJECT EXPERIENCE**

 

**FDA meeting and IND submission**

- Write and prepare the letter and the list of questions to request a pre-IND meeting with the FDA
- Write and prepare pre-IND Package 
- Attend ≈20 FDA meeting (i.e pre-IND meeting and Type C meeting) as a coordinator or scribe depending on the need from the Sponsor
- Write and prepare the IND in a eCTD format (modules 1, 2, 3, 4 and 5)
- Submit IND electronically
- Maintenance of IND as amendment and annual report

 

Product and therapeutic area

- Two (2) HIV viral vector vaccine and one investigational vaccine with the Division of Vaccines and Related Products Applications (CBER)
- One (1) rotavirus vaccine exUS development (Australia and South Africa))
- One (1) antibacterial vaccine (CBER)
- Eight (8) stem cell products with the Office of Cellular, Tissue and Gene Therapies (CBER)
- Three (3) investigational products with the Division of Cardiovascular and Renal Products
- Three (3) investigational products with the Division of Dermatology and Dental Products including one dermatological/cancer investigational product
- One (1) investigational products with the Division of Gastroenterology and Inborn Errors Products
- Two (2) investigational products (one biosimilar and one small molecule) with the Division of Pulmonary, Allergy and Rheumatology Products
- One (1) investigational product with the Division of Bone, Reproductive and Urologic Products
- Two (2) investigational products with the Division of Hematology Products
- Three (3) combination product for neuro/oncology products
- Three (3) investigational product with the Division of Neurology Products

 

**Pre-NDA meeting and information package submission**

- Write and prepare the letter and the list of questions to request a pre-NDA meeting:
- Write and prepare pre-NDA Package 

 

**Orphan designation Application **

- Write and prepare the orphan designation application
- Write and prepare orphan grant application

 

Product and therapeutic area

- One stem cell product
- Two (2) cardiovascular investigational product
- One dermatological investigational product
- One small molecule GI tract
- One for DMD indication
- One for ALS indication
- One for combination product for oncology product
- Two (2) for pancreatic cancer
- One for narcolepsy

 

**Clinical Investigator’s brochure**

- Write and prepare/update IB from nonclinical and clinical study reports

 

Product and therapeutic area

- One HIV viral vector vaccine 
- One Rotavirus Vaccine
- One stem cell product
- Two dermatological investigational products
- One dermatological/cancer investigational product

 

**Clinical protocol**

- Write and prepare a draft clinical protocol to be edited by the principal investigator

 

Product and therapeutic area

- One dermatological investigational product
- One Rotavirus product

 

**BLA, NDA and ANDA submission**

- Write and Prepare two NDA 505(b)(2) pathway for opioid product and injectable product
- Write and prepare NDA 505(b)(2) pathway (Module 3 and Module 2 QOS) for a combination product (pump and product)
- Write and prepare a BLA modules 2 and 3 for a blood product
- Write and prepare a BLA modules 2 and 3 for a stem cell product
- Write and prepare Module 3 for a BLA application from batch records and SOPs and Module 2 for two conjugate vaccines, submission through mutual recognition and centralised procedure in Europe and US and follow-up
- Write and preparation Modules 2, 3 and 4 of a CTD for an Hepatitis B vaccine
- Write and prepare Module 3 and Module 2 for a 505(b)(2) NDA for a opioid product
- Write and prepare 505(b)(2) NDA modules 1, 2, 3, 4 and 5 for a combination device-drug (reformulation of an existing product) – and submit electronically
- Prepare four (4) 505(b)(j) ANDA modules 1, 2, 3 and 5 and submit electronically 
- Preparation of 8 DMFs for conjugate vaccine products and silver API

 

**BLA, NDA and ANDA Post Approval submission/CRL Responses**

- Assist in the preparation of 3 Complete Response Letters (CRL) 
- Use several amendments to update a BLA NDA modules 2 and 3 for several vaccine products (Flu-type)
- Convert and update Module 2 and Module 3 for 4 antibiotic products
- Convert a PreApproval Supplement into a Type 2 Variation for European submission for a vaccine product

 

**DMF submission**

- Review and submit electronically 5 DMF for a European API facility
- Review and submit electronically 3 DMF for an Argentinian API facility 
- Assist in FDA inspection 
- Prepare and submit electronically Drug Establishment Registration and Self Identification
- Maintenance of all DMFs

 

**Electronic Submission**

- All IND and NDA/BLA were prepared for electronic submission
- Lorentz Software for publishing 
- Submission via the FDA Gateway Portal

 

**Regulatory Compliance**

- Evaluation of the process validation for a monoclonal antibody with emphasis on leachables and extractables.
- Preparation of SOPs, Batch Records and technology transfer to GMP manufacturer for a viral vaccine delivery system.  
- Audits of research laboratories (GLP oriented) for IND purposes and preparation of manufacturing plant (GMP oriented) for FDA pre-approval inspection.  
- Review all CAPA for all vaccine products for a Big Pharma

**PROFESSIONAL EXPERIENCE**

 

**2000-present** **Industry Consultant**

***Denver, CO, USA***

 

**1998-2000** **Regulatory Affairs Associate**

 

**1996-1998** **Senior Regulatory Affairs Executive**

***VALORUM Inc, Research Triangle Park, NC,  USA

***

** Regulatory Affairs Manager**

***PHARMAKOPIUS INTERNATIONAL Ltd - READING, UK***

 

**1995-1996 Regulatory Affairs Consultant**

***EUROPEAN REGULATORY AFFAIRS - READING, UK***

 

**1994-1995 Project Manager Assistant**

***APPLIED MICROBIOLOGY, Inc - NEW YORK, USA***

 

**1992-1994 Post-Doctoral Scientist**

***REGENERON, Inc - NEW YORK, USA***

 

**1987-1992 PhD Program **(*Mr le Professeur J Cros)*

***LABORATOIRE DE PHARMACOLOGIE ET TOXICOLOGIE FONDAMENTALES - TOULOUSE, FRANCE ***

 

**1986-1988 Master of Science**

***SANOFI RECHERCHE - LIGNES PEPTIDES - TOULOUSE, FRANCE***

**EDUCATION**

 

- **PhD Program - Option Cell Biology and Biochemistry**

Supervisor: Dr M Webber

Purification and characterisation of two cholinergic differentiation factors.  Laboratoire de Pharmacologie et Toxicologie Fondamentales - Toulouse, France

 

- **Master of NeuroSciences and Behavioural Studies**

Study of neurodegenerative diseases of both central and peripheral nervous systems.  Université Paul Sabatier - Toulouse, France

 

**LANGUAGES**

 

English - fluent

French - fluen

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