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FDA Ready Consulting

FDAready.com: an FDA Investigator and industry associates solving GMP compliance problems in biotechnology, pharmaceuticals, and high tech in vitro diagnostics.

http://www.fdaready.com/

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FDA Ready Consulting | fdaready.com Reviews
<META>
DESCRIPTION
FDAready.com: an FDA Investigator and industry associates solving GMP compliance problems in biotechnology, pharmaceuticals, and high tech in vitro diagnostics.
<META>
KEYWORDS
1 Greg Bobrowicz and Associates
2 Gregory Bobrowicz
3 Gregory M. Bobrowicz
4 Greg Bobrowitz
5 Gregory Bobrowitz
6 Gregory M. Bobrowitz
7 pharmaceutical
8 pharmaceuticals
9 cgmp
10 cgmp's
CONTENT
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KEYWORDS ON
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fda ready,code of ethics,inspection prep strategy,services,clients,cmos and outsourcing,qualifications,partnerships,identify compliance gaps,training,compliance gap analyses,mock inspections,fdaready
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FDA Ready Consulting | fdaready.com Reviews

https://fdaready.com

FDAready.com: an FDA Investigator and industry associates solving GMP compliance problems in biotechnology, pharmaceuticals, and high tech in vitro diagnostics.

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1

FDA Ready Consulting

http://www.fdaready.com/clients5.htm

Are You FDA Ready? FDAReady provides services to companies throughout the product development lifecycle. Commercial companies need assistance with regulatory problems, internal audits, or issues with their suppliers. Some commercial companies are seeking financial efficiencies while maintaining compliance. Phase 3 companies are preparing for a pre-approval inspection. Early Phase companies are establishing compliance strategies and policies.

2

FDA Ready Consulting

http://www.fdaready.com/part5.htm

Are You FDA Ready? Greg Bobrowicz is a member of an informal network of former FDA staffers and outstanding independent consultants. FDAReady works closely with select independent consultants with industry experience to implement larger projects efficiently and cost-effectively.

3

FDA Ready Consulting

http://www.fdaready.com/qual5.htm

Are You FDA Ready? Click here for this CV as a printer-friendly pdf. International expert in FDA GMP Compliance and Quality Assurance. Experienced in performing the most complex FDA inspections and industry audits. Expert in FDA GMP requirements for pharmaceuticals, biotechnology, and ICH Q7A. Practical and systematic corrective action plans tailored to address FDA’s greatest concerns about product quality. Excellent speaking and writing skills. Comprehensive and proven approach to hosting inspections.

4

FDA Ready Consulting

http://www.fdaready.com/index.htm

Are You FDA Ready? Are you FDA Ready? To be ready, a company needs to. Implement solutions that work. Present material to FDA effectively. Greg Bobrowicz is an internationally-recognized expert in GMP compliance for biopharmaceuticals, novel dosage forms, and quality systems . Since 1998, he has been a critical member of the PAI preparation activities for many successful high-profile products. FDA inspections are inconsistent and unpredictable . FDA inspections focus on results, not good intentions .

5

FDA Ready Consulting

http://www.fdaready.com/codeethics.htm

Are You FDA Ready? FDAReady works with products that represent a significant therapeutic option over existing therapies. FDAReady will work with significant products that are intended to be less expensive and more available than existing options. While no company is 100% in compliance, FDAReady will only attempt to persuade a regulatory body or partner to accept a compliance condition if a company accepts the condition internally. FDAReady works hard to keep up on current policies. When FDAReady is worki...

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FDA Ready Consulting

Are You FDA Ready? Are you FDA Ready? To be ready, a company needs to. Implement solutions that work. Present material to FDA effectively. Greg Bobrowicz is an internationally-recognized expert in GMP compliance for biopharmaceuticals, novel dosage forms, and quality systems . Since 1998, he has been a critical member of the PAI preparation activities for many successful high-profile products. FDA inspections are inconsistent and unpredictable . FDA inspections focus on results, not good intentions .

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Welcome to the Fort Dodge Area Landlord Association (FDALA) Website! - Home Page

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Welcome to the Fort Dodge Area Landlord Association (FDALA) Website! - Home Page

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FDA says "No" to Congress

FDA says "No" to Congress. Saturday, January 08, 2005. A Humane Request Denied. The following letter presents a simple request. Four members of the U.S. House of Representatives and one U.S. Senator urged the FDA to grant a request for 'emergency IND' approval, permitting an ALS patient who had. Benefited from cord blood transfusions to resume the treatments. At present the patient cannot speak, eat, breathe, or move. The physician to announce that the request had been denied. December 21, 2004. In recen...