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Peter Manilla | Elance
 
176985602337900
Last Sign-in: Jul 12, 2014

Peter Manilla

FDA Regulatory Affairs Consultant
   United States
  |   Silver Spring, MD
  |  7:53 am Local Time

Verified Freelancer

Peter Manilla's identity has been verified.  Learn More

Overview

Minimum Hourly Rate $110
  |  
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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).

Read More »
May 14, 2014|Other Legal Services|Private|Completed
|
4.9
Apr 15, 2014|Other - Legal|Private|Completed
|
5.0
Apr 15, 2014|Other - Legal|Private|Completed
|
4.5
Mar 9, 2014|Business and Corporate|Private|Completed
|
5.0

View All »

Portfolio

For 510(k) pre-submission.
For FDA 510(k) pre-submission.
For FDA 510(k) pre-submission.
For medical device clinical performance and safety study.

Skills (10)

Tested
ISO 9001
ISO 9001
My Score
avg
Grant Writing
Grant Writing
My Score
avg
GxPs/QSR
Project Management
Project Management
My Score
avg
Report Writing
Report Writing
My Score
avg
Passed
FDA/FTC review of websites
Dietary supplement labeling
Medical Devices
FDA
Technical Writing
Technical Writing
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,
Label review and compliance
Website review and analysis for compliance to FDA and FTC requirements
FDA registration and product listing, and
US FDA foreign company representative.

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Employment

Manilla, LLC
Owner
2014 - Present
Company provides freelance FDA regulatory affairs and compliance consulting services.

Education

Johns Hopkins University
Masters of Science in Biotechnology
-

Keywords

GMP
FDA
FTC
510(k)
orphan drugs
ISO
Medical Writing
Dietary Supplements
Website Advertising
Labeling
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
9
5
52
Total
Milestones
Hours
Reviews
4.9
Recommend
Clients
Total
Repeat
Earnings
Private
Private
Total
Per Client
Identity
Username
pm2351
Type
Individual
Member Since
April 2012
Elance URL
Verifications
Peter Manilla | Elance

Peter Manilla