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PHARMACEUTICAL INDUSTRY :
R&D Analytical Laboratory Improvement |
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Client: |
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A
major consumer pharmaceutical developer, manufacturer and supplier,
with trusted and popular brands. The client supplies products in multiple
dosage forms, with total global revenues exceeding $1 billion annually.
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Problem: |
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The
firm was resource-constrained in its R&D analytical laboratories.
This created a backlog of testing and impacted responsiveness to total
business needs. Methods development and validation processes were
not being properly supported and scientific staff lacked necessary
skills. The firm needed to complete process validations and product
transfers for new product launches. |
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Approach: |
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The
client is now consistently managing the volume and diversity of laboratory
work, and has successfully met both internal corporate and external
FDA audits. Tunnell has assisted the client on the many critical fronts
essential for success: production transfer, scale-up, new product
launches, methods development and validation, and analytical testing
services. |
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Results: |
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Tunnell Consulting entered into an ongoing long-term partnership with the client, already lasting several years, and was ultimately selected as the client's sole supplier of outsourced analytical and validations services. We provided the following:
TC assigned high-caliber, experienced scientists to develop and validate methods, address routine testing requirements, and relieve backlogs
TC scientists became qualified on client SOPs, lab protocols, data formats, data systems, policies and procedures
TC scientists organized, planned, and supervised work teams of analytical chemists, working at client facilities and on client equipment, consistent with cGMP standards
TC scientists performed analytical testing across multiple consumer products and dosage forms
TC project managers organized data, developed reports, and facilitated the report review and approval process
TC provided expert resources to support both routine R&D laboratory testing and clinical/regulatory submissions
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