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The client was a university-based public health research organization looking to study the health effects of MRI contrast agents after the EMA suspended licensing of intravenous contrast agent in the EU
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DownloadOperational Excellence
Client was a large US pharmaceutical company looking to develop organizational competence to identify systemically and proactively the contributory causes of human error in pharmaceutical manufactures.
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DownloadFacility Design
Client was a medium-sized US company looking to build a new Aseptic Compounding and Fill-finish facility to handle highly potent compounds.
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DownloadQuality Management System
Client was a large Canadian pharmaceutical company requiring an experienced provider to develop the Quality Management System for their supply chain and distribution office.
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DownloadRx-to-OTC Switch Safety Support
Client was a large pharmaceutical company requiring an adverse event analyses in five safety databases and a literature review in support of the Rx-to-OTC NDA submission.
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DownloadComparative Effectiveness Study
Client was a large pharmaceutical company requiring an examination of the comparative effectiveness of dronedarone used to treat atrial fibrillation relative to other drugs with the same indication in a real world setting.
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DownloadDescriptive analysis of a rare & fatal adverse event within the FDA Adverse Event Reporting System (FAERS)
Client was a large pharmaceutical company requiring development of methodology and conduct of a longitudinal review as part of the pharmacoepidemiology evaluation of progressive multifocal leukoencephalopathy (PML).
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DownloadAssessment of Risk Management Plan Impact on Physician, Pharmacist & Patient Knowledge
Client was a large pharmaceutical company requiring development of methodology and assess the effectiveness of the drug risk management plan for a new phosphodiesterase type 5 (PDE-5) inhibitor for treatment of erectile dysfunction.
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DownloadAutologous cell product (cartilage defect)
Client was a small biotech company developing an autologous cell product for cartilage defects
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DownloadFeasibility evaluation of obtaining OTC classification for two anti-inflammatory drugs
The client had developed two anti-inflammatory drugs and needed support with a feasibility evaluation about obtaining OTC classification and establishing a global development & regulatory plan.
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DownloadDevelopment plan for Immune suppressant in a specific indication within the Orphan Condition tuberous sclerosis
Immune suppressant to be applied as subcutaneous application in a specific indication. Client aimed for a hybrid application with reference to the originator.
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DownloadStrategic Outsourcing - transfer of global Maintenance Activities
Multinational EU-based innovator company requiring transfer of all global maintenance activities for a portfolio of mature products.
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DownloadFull service post-marketing and clinical trial PV activities for mid-sized pharma company
A US company developing modified release formulations for existing active ingredients was in need of
appointing an EU-QPPV. The client gradually transferred PV tasks to PharmaLex resulting in full responsibility of all their PV activities with PharmaLex
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DownloadM&A Regulatory Support – Initial Situation
Client required 3,500 marketing authorizations (MA) in >120 countries. Country dossiers needed to be transferred as well as global dossiers. Processes for MA transfer needed to be designed (globally & locally) and MA transfer need to be supported operationally as of Day 0 (closing).
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