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Peter Manilla | Elance
 
176985602337900
Last Sign-in: Jul 1, 2015

Peter Manilla

FDA Regulatory Affairs Consultant
   United States
  |   Silver Spring, MD
  |  12:06 pm Local Time

Verified Freelancer

Peter Manilla's identity has been verified.  Learn More

Overview

Minimum Hourly Rate $71
  |  
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FDA regulatory affairs certified (RAC) professional and GMP certified professional (GMPCP) with in-depth knowledge of FDA drug, biologic and medical device regulations (Code of Federal Regulations, Title 21, Food and Drug Administration (21 CFR).

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Jun 19, 2015|Other Legal Fields|$219|Completed
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5.0
Mar 25, 2015|Other - Legal|$438|Completed
|
5.0
Dec 29, 2014|Other Legal Fields|$219|Completed
|
5.0
Dec 28, 2014|Other Legal Services|$30|Completed
|
5.0

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Portfolio

Skills (10)

Tested
FDA
GxPs/QSR
Labeling
Dietary Supplements
FTC
Medical Devices
Grant Writing
Grant Writing
My Score
avg
Project Management
Project Management
My Score
avg
Statistics
Statistics & Probability
My Score
avg
Passed
ISO 9001
ISO 9001
My Score
avg

Service Description

FDA regulatory advice and strategy,
FDA cGMP/GLP/GCP compliance,
FDA submissions (IND/NDA/BLA/510(k)),
Medical Device classification,
Dietary Supplements,
Review of advertising, labeling and websites
FDA registration and product listing.
.

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Employment

Manilla, LLC (http://www.manillallc.mobi)
Owner
2014 - Present
Company provides freelance FDA regulatory affairs and compliance consulting services.
DoD Joint Project Management Office - CBMS
Deputy Director, Regulatory Affairs
2005 - Present
VirxSYS, Inc.
Director, Regulatory Affairs
2002 - 2005
OMRIX Biopharmaceuticals, Inc.
Director, Regulatory Affairs
1999 - 2001
Food and Drug Administration
CDER/Consumer Safety Officer
1982 - 1991

Education

Johns Hopkins University
Masters of Science in Biotechnology
-

Keywords

FDA regulatory compliance
510(k)
medical device
drug
dietary supplement
writing
advertising
labeling
FTC
My Snapshot
8
Elance Level
Level represents activity and experience on Elance. Freelancers start at Level 1 and achieve higher levels through their work. A higher "Level" indicates greater earnings, ratings and other achievements on Elance. Learn More »
  • 12 months
  • Lifetime
Jobs
10
3
26
Total
Milestones
Hours
Reviews
5.0
Recommend
Clients
Total
Repeat
Earnings
Total
Per Client
Identity
Username
pm2351
Type
Individual
Member Since
April 2012
Elance URL
Verifications
Groups
Peter Manilla | Elance

Peter Manilla