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FDA Mock audits conducted by FDA consultants Perkins and Perkins, Inc. GCP TRAINING,COMPLIANCE ISSUES, PREVENT 483'S RESPOND TO 483'S, NEGOTIATE WITH FDA, PRE IND, PRE IDE OR 483

Mock FDA audits conducted by FDA consultants Perkins and Perkins, Inc. assist pharmaceutical or medical device industries. Request a mock FDA audit to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation

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FDA Mock audits conducted by FDA consultants Perkins and Perkins, Inc. GCP TRAINING,COMPLIANCE ISSUES, PREVENT 483'S RESPOND TO 483'S, NEGOTIATE WITH FDA, PRE IND, PRE IDE OR 483 | xfda.net Reviews
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Mock FDA audits conducted by FDA consultants Perkins and Perkins, Inc. assist pharmaceutical or medical device industries. Request a mock FDA audit to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation
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1 Advisor to drug and pharmaceutical industry
2 IRB Audit
3 X FDA
4 PRE IND MEETINGS
5 FDA advisor
6 FDA advisor
7 FDA advisor
8 FDA audit preparation
9 Consultant
10 FDA
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perkins and perkins,capabilities,tips,our successes,drug and devices,hot topics,jerri's cv
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FDA Mock audits conducted by FDA consultants Perkins and Perkins, Inc. GCP TRAINING,COMPLIANCE ISSUES, PREVENT 483&#39;S RESPOND TO 483&#39;S, NEGOTIATE WITH FDA, PRE IND, PRE IDE OR 483 | xfda.net Reviews

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Mock FDA audits conducted by FDA consultants Perkins and Perkins, Inc. assist pharmaceutical or medical device industries. Request a mock FDA audit to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation

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May | 2009 | Jerri's Blog

https://jerribperkins.wordpress.com/2009/05

Just another WordPress.com weblog. May 14, 2009. New Era at FDA. Posted in FDA Expert. At 6:41 pm by jerribp1. Will FDA reverse itself? How will this re-evaluation affect medical device manufacturers? Medical device companies can expect more stringent approval criteria in the future. The rules and regulations at FDA traditionally tighten after a controversial decision and particularly when Congress becomes involved. Companies can no longer rely on what worked in the past. It’s a new era at FDA. One quest...

jerribperkins.wordpress.com jerribperkins.wordpress.com

Former FDA Medical Officer; “an insider perspective” | Jerri's Blog

https://jerribperkins.wordpress.com/2009/05/07/former-fda-medical-officer-an-insider-perspective

Just another WordPress.com weblog. May 7, 2009. Former FDA Medical Officer; “an insider perspective”. Posted in FDA Expert. At 5:27 pm by jerribp1. One question consistently asked is will we be audited . If you are involved in clinical research, expect to be audited someday. What is new is the recent. IRB sting operation, which revealed that one of the 3, IRBs selected failed in responsibility. IT was not the FDA but the GAO who conducted this operation. The question is will FDA intensify IRB scrutiny?

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CONTRACT SERVICES/REVIEW AND ADVICE. Consulting provides contract services for the approval of Drugs, Biologics and Medical Devices by the Food and Drug Administration (FDA). Consists of more than 70 consultants formerly FDA experts involved in the drug, biologic and medical device approval processes. We offer a wide range of advice and services from preclinical trials, drug, biologic and medical device development, clinical trial protocols and support through the approval process and beyond. Experts can...

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FDA Mock audits conducted by FDA consultants Perkins and Perkins, Inc. GCP TRAINING,COMPLIANCE ISSUES, PREVENT 483&#39;S RESPOND TO 483&#39;S, NEGOTIATE WITH FDA, PRE IND, PRE IDE OR 483

Looking for FDA Assistance? Let a former FDA Medical Officer help you. Dr Perkins has successfully worked with pharmaceutical and medical device companies. Dr. Perkins saved sites from getting 483s, propelled non-approval products to market, helped get first patient into clinical trials, negotiated labeling issues and helped companies resolve 510k and PMA issues. By asking companies the right questions, Dr. Perkins has saved companies time and money with regulatory strategy.

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