Past projects

Here are some few examples of how we helped our clients:

• Established a GMP facility, by developing the Quality Management System (QMS), providing GMP training, compiling the Biologic License Application which included sections for Establishment Description, Safety/Purity/Potency, Chemistry (CMC), Summary Report, and prepared the facility for FDA Pre-Approval Inspection, passed the inspection with no findings, and shipped the first shipment valued at $6.8M.

• Provided regulatory and technical support to pharmaceutical and medical device clients to improve their Validation, CAPA, Training, and Auditing processes after receiving Warning Letters from The FDA. The end result was the closure of these Warning Letters and putting our clients on the path of sustainable compliance.

• Improved the compliance level of a client’s organization by developing an internal audit program and utilizing the audit findings as inputs to improve the effectiveness of their CAPA and Training processes.

• Developed numerous CAPA programs (using DMAIC, 8D, and PDCA Methodologies) for medical device and pharmaceutical companies, provided training, and cleared backlogs of open CAPAs to prepare these companies for the next FDA inspections.

• Established Master Batch Records and Performed thousands of Batch Record Reviews for major pharmaceutical clients, and developed remediation plans to address a Warning Letters observations. The result of our efforts helped our clients avoid further regulatory enforcement actions by the FDA.

• Designed CAPA training programs for thousands of employees, and mentored numerous CAPA Investigation Leaders on how to use Root Cause Analysis Tools, which helped our clients in their effort towards getting re-certified after Consent Decrees.

• Validated ETQ Reliance software and incorporated inputs from the Non-Conformance, Calibration & Maintenance, Complaints, Audits, Supplier Quality Management modules to the CAPA process, and used those inputs as trigger points for CAPA initiation and provided training. The same approach was implemented for other software programs (Master Control, Pilgrim, .. etc.) for other clients.

• Developed numerous cleaning validation protocols, coordinated the implementations, and wrote the final reports for a pharmaceutical and biologics manufacturing process, after qualifying the related equipment (IQ/OQ/PQ) including process vessels, chromatography columns, skids, centrifuge, CIP, buffer preparation, and glassware washer.

• Wrote the protocols, coordinated the implementation of three cleaning validation studies for a pharmaceutical client in support of the development and manufacturing of three nasal inhalation drug products.

• Utilized lean six sigma methodology to solve a problem of low efficiency due to duplication efforts and data loss, caused by manual transfer processes and lack of integration of lab workflows systems as well as non-value added steps and variability, by the introduction of electronic laboratory notebook for 300 scientists at different sites.

• Used Design of Experiment (DOE) to resolve a dissolution variation problem caused by a complex relationship between process variables and raw material properties, by identifying key interactions between raw materials and process variables. This technique helped me identify the need to tighten raw material specs and the product was successfully launched in 1 year.

• Used Lean Six Sigma methodology to reduce the error rate of a Device History Record (DHR) for a medical device company by implementing a three-tiered approach which included technology, process, and people related solutions. This approach helped me realize a 35% reduction in overall record errors.

• Improved Sample Management System (Pre-analytical, Analytical, and Post-analytical) by establishing and implementing Six-Sigma DMAIC Methodology for a CLIA laboratory, which helped the client win projects from the Department of Veteran Affairs. The result of our efforts helped the client increase the number of analyzed samples from few thousands to over 16 million samples/year in the following year.

• Commissioned a cGMP Laboratory to support a GMP manufacturing facility, by procuring and qualifying the laboratory analytical instruments, writing the Validation & Verification protocols for the Software LIM System (Agilent Open Lab Software), and developing the stability programs for three different drug products, and providing training to and mentoring the technical staff.

• Coordinated cross-functional project teams for the development of nine pharmaceutical drug products, including Analytical Methods Development, Stability Studies, Cleaning Validations, and Method Transfer.

• Led a team of scientists and regulatory compliance specialists to perform Analytical Method Transfer Gap Assessment for 136 analytical methods for a major pharmaceutical client. The outcome of the gap assessment was determining that the methods were not validated according to approved protocols. We optimized these methods using chromatographic and spectrometric techniques, wrote the validation protocols, trained some of the laboratory analysts on how to execute the protocols, and completed the validation effort.

• Performed Dissolution, Stability, and Leachable/Extractable studies, as well as identified and quantified residual solvents for nine drug products using analytical instruments such as HPLC, GC-MS and LC-MS/MS.

• Optimized the Supplier Management System for a major biotechnology company, followed by performing 53 external audits for their supply chain. Our effort resulted in persuading the suppliers of our client to address many compliance issues that were overlooked during previous audits, and the suppliers were initially reluctant to address them.

Valued Clients we have served:


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