Global BioPharmaceutical Resources Inc.

2719 Woodgate Way
Roseville, CA 95747
Tel:916-773-1470
Fax:916-608-4200
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www.ComputerSystemValidation.com

 Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 192 mission critical laboratory, clinical, and manufacturing software implementation projects.

Services include compliance related to product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.

His latest book is "Risk Based Software Validation - Ten easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.

David Nettleton is the co-author of "Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164" (Interpharm/CRC - www.crcpress.com, 2004), and "Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance" (Davis Horwood International and PDA - www.pda.org, 2003).

237 Chapel Lane
King of Prussia, PA 19406-1824
Tel: 610-265-9029
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www.gentechadvisors.com

Packaging Science Resources Provides consulting and training in packaging for the pharmaceutical, biotechnology, and medical device industries. Services include:
• Development of Extractables and Leachables Management Strategies
• Total Package Development for Parenteral Drug Products
• Guidance on Cold Chain Transport and Storage for Vaccines and Temperature Sensitive Pharmaceuticals
• Specification and Test Protocol Development for Packaging Materials and Components
• DMF Preparation and Filling
• Guidance on Compliance with FDA, USP, Ph.Eur., JP, and ISO
• Training and Packaging Principles, Practices, and Regulations

17 Agnes Court
Melville, NY 11747
Tel: 516-375-7990
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URL: www.trotterbiotech.com

Specializing in technology transfers & training

At Trotter Biotech Solutions, we focus our products and services specifically to the Biopharmaceutical Industrial markets. A broad range of technology transfer and training products provide our customers with opportunities to tailor programs to their specific requirements. We offer workshops, seminars and consulting services in upstream and downstream biopharm manufacturing applications and validation needs, from separation, clarification and purification technologies to single-use (disposables) and final sterilizing filtration applications and processes.

Office: (520) 498-0427
Cell: (520) 940-0481
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URL: www.OnTargetConsultants.com

On Target Consultants was founded by Chuck Bolotin.  Chuck founded and sold two companies and led the product introduction of a dozen more.  Most recently, Chuck was responsible for creating and leading the very successful introduction of BioVigilant’s product to the pharmaceutical industry.

On Target Consultants provides unparalleled:

• “Go to market” / commercialization strategy and execution, including market and product requirements, company and product positioning.
• Revenue acceleration (such as when the client’s team isn’t achieving its revenue and profit projections).
• Partnering and asset sales.
• Due diligence for investors and companies.

On Target Consultants’ clients include investors, start-ups, and mid-size to larger companies and institutions seeking to bring their product to market.

Your bridge to success

Chuck Bolotin
Office: (520) 498-0427
Cell: (520) 940-0481
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URL: www.ArchPartnersLLC.com

Arch Partners was formed to address an urgent and unsatisfied need: providing expert management advice and execution for companies bringing their product to market, at no immediate cash cost to the portfolio company.  Collectively, the partners bring top notch expertise in everything from “go to market” strategy and execution to exit strategy and execution, along with all the higher value requirements in between.  The portfolio companies choose what they need.

Each of the partners in the company have first rate experience successfully growing companies from inception or close to inception all the way to what many times were very lucrative exits.