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CASE STUDIES

We work closely with our clients to address their business obstacles by employing innovative, timely, and compliant solutions. Below are a sample set of case studies highlighting project conditions we have encountered and the solutions we have implemented.

 

Validation and Compliance Project Case Study

The Situation: US based global Fortune 500 healthcare company sought assistance with validation and compliance consulting services for test method, process and database validation consulting services for its diagnostics division. Client also requested Protocol Link’s assistance for validation and compliance consulting services in support of a consent decree signed with the U.S. Food and Drug Administration (FDA).

Our Solution and Results

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Validation Support Project Case Study

The Situation: US based Fortune 500 healthcare corporation sought assistance from Protocol Link to provide validation support services for equipment qualification, computer validation, and cleaning validation at its FDA-regulated repackaging facility.

Our Solution and Results

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Computer / Software Validation Project Case Study

The Situation: US based manufacturer of large sterile parenteral drug products sought assistance from Protocol Link with computer network and software validation consulting services.

Our Solution and Results

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Management and Compliance Project Case Study

The Situation: US based leading solid dosage manufacturer sought assistance from Protocol Link to provide management and consulting support in the areas of responses to FDA-483 observations, quality systems, compliance assessments, operations, batch certification and release, cGMP documentation, and personnel training.

Our Solution and Results

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Process Improvement and Compliance Project Case Study

The Situation: US-based leading pharmacy services provider of sterile IV and epidural preparations for pain management sought assistance from Protocol Link in the area of process improvement, compliance, and technical services.

Our Solution and Results

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ANDA CTD Submissions Project Case Study

The Situation: US based global manufacturer of injectable pharmaceutical products with manufacturing and packaging facilities located in Europe sought assistance from Protocol Link to prepare and submit Abbreviated New Drug Applications (ANDAs) for its drug products to the U.S. Food and Drug Administration (FDA).

Our Solution and Results

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cGMP Compliance Strategy Implementation Project Case Study

The Situation: Netherlands and US based pharmaceutical firm (client) sought assistance with cGMP audits of contract sites, including Drug Substance (DS) and Drug Product (DP) suppliers, manufacturing facilities, stability testing labs, packaging sites, analytical testing labs, and warehouse and distribution centers.

An exhaustive gap analysis was performed to identify additional tasks, with an emphasis on Quality System infrastructure SOPs, specifications, technical agreements, master batch records, annual product reviews (APR), a central filing system for cGMP records, product transfer and validation strategies, personnel training programs, product complaint investigations, and readiness for FDA inspection.

Our Solution and Results

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Compliance Consulting and Product Recall Project Case Study

The Situation: A major US-based solid dosage repackaging corporation (client) experienced multiple recalls of its products due to product mix-ups occurring within its processes. The client sought assistance from Protocol Link to provide cGMP compliance assistance to identify root causes, redevelop the quality systems to prevent recurrence, and manage the product recall efforts to closure.

Our Solution and Results

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cGMP Compliance Audits Project Case Study

The Situation: US based pharmaceutical firm (client) requested Protocol Link consulting to perform cGMP vendor qualification audits at its current and proposed, third-party API manufacturers (including a beta-lactam facility), analytical laboratory, and parenteral drug product manufacturers across Europe and Asia. Protocol Link provided scheduling, coordination, and performance of these audits.

Our Solution and Results

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cGMP Remediation and PAI Readiness Project Case Study

The Situation: Ireland and US-based pharmaceutical company (client) sought assistance with ensuring its third-party manufacturer based in Italy would pass FDA inspection to manufacture a sterile injectable drug for US distribution. An initial punch list of potential remediation items was created previously through internal reviews and audits that became a starting point for Protocol Link’s scope of remediation services.

Protocol Link was hired to assist with remediation of these items, identify other areas for immediate improvement deemed critical for a successful cGMP inspection, and prepare the manufacturer for its very first US FDA PAI. In addition, the client requested Protocol Link’s daily on-site support and direct FDA liaison assistance during the PAI in Italy.

Our Solution and Results

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