FORZA PHARMA CONSULTING
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​The Forza mission

​Successful development of pharmaceuticals and diagnostics requires competent execution of thousands of specialties in turn - many of them only transiently needed.  Forza Pharma Consulting was established to allow growing companies access to these skills in a way that suits their immediate needs.  Forza was founded in August 2018 to provide project-specific expertise to growing life-sciences companies in the San Francisco Bay Area.  We specialize in validation science and validation management required to advance therapies and devices according to FDA and EMA guidelines.  We have personal experience successfully presenting our client documentation to FDA auditors when selected for review.
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Welcome to Forza Pharma Consulting

small molecules to biosimilars
cell vial to packaged drug product
project inception to marketed medicine

Validation Science

Modern validation practices are based on objective analysis of risk.  Our primary driver is prevention of patient risk, with concurrent consideration of compliance and business risks.  From commissioning to qualification to validation, scientific risk analysis is the proven methodology by which we guarantee the quality of our services and our clients' products.​

Validation Management

Your enduring documentation of equipment, cleaning, and process validation is what will allow continued uninterrupted of production capacity.  We offer environmental and utilities regulation from controlled non-classified space to Class I air handling, equipment qualification from production to analytical QC instrumentation, and a wide variety of process and cleaning validation services for traditional and personalized diagnostics and therapeutics.

Quality Affairs

Documents produced by Forza authors are routinely subjected to regulatory review and stand up well to auditor scrutiny, even when defended much later by hosts unfamiliar with the work.  From technical assessments of equipment/process to investigations of potentially product-impacting deviations, all quality documentation is right the first time, inclusive of Good Documentation Practices.

Project Management

Enterprise projects require large teams, with all stakeholders aligned on goals and timelines.  Skilled Project Management is required in all phases, from initiation and preparatory planning through execution and closeout activities.  Early identification and communication of all project requirements in allows us to create a fast but realistic schedule, resulting in on-time completion and client satisfaction.
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