Operational 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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Facility 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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Quality 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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Rx OTC SwitchRx-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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Comparative EffectivenessComparative 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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Adverse eventDescriptive 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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Risk ManagementAssessment 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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Autologous cell product (cartilage defect)

Client was a small biotech company developing an autologous cell product for cartilage defects

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Feasibility 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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Development 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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Strategic 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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Full 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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M&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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