VPCI personnel has sucesfully handled projects from initial stages prior to filing all the way to market release and continuous collaboration with the client during the product life cycle.
Services can be as simple as a facility audit all the way to registering a product and seeing it through to finding an advantageous in – licensing partner.
Whether it is an Italian-based Technology Transfer project, a Mexican-based Pharmaceutical plant start-up, or a U.S.-based validation program, VPCI has the exact people needed for the job.
We are able to communicate in a variety of languages, are highly skilled, and professional.
Below is a listing of some of the areas of expertise we are able to offer. Our capabilities however go far beyond this partial listing:
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General
Pharmaceutical plant management. |
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FDA
Regulatory compliance. |
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New
Drug Application filing coordination. |
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Critical
System computer controls design, testing and validation. |
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Process
controls and measurements. |
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Pharmaceutical
operations management. |
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Pharmaceutical
plant start-ups. |
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Pharmaceutical
plant efficiency planning. |
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Critical
utility system design. |
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GMP
audits and reviews. |
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Validation
Master Plans. |
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GMP
Compliance. |
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Commercialization
of products. |
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Clinical
trial management. |
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Pharmaceutical
facility management. |
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Quality
Assurance and Quality Control. |
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Computer
system validation. |
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Major
project management. |
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ISO
9000 Audits. |
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Gap
analysis audits. |
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Validation
program management. |
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Technology
transfer management. |
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QA/QC
laboratory management. |
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Microbiology
/ Rapid Microbiology. |
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FDA
New Drug Applications and strategies. |
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Clinical
trial management. |
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In
and Out-Licensing representation. |
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Hands-on,
FDA Regulatory experience. |
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Regulatory
program development. |
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Sterilization. |
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European
Regulatory Agency regulatory filing. |
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