Freestream Solutions provides strategic business process transformation, organizational change management, and technology consulting services to Fortune-500 companies, primarily in the pharmaceutical and biotechnology industries. Our consultants are dedicated to helping our clients achieve significant improvements in business performance. We don't just have innovative ideas - we work side-by-side with our clients to help ensure the benefits are realized and our knowledge is transferred successfully.
With Freestream Solutions you can benefit from our insatiable appetite for ensuring that the solutions we provide are not only innovative, but also embedded in the organization, with stakeholders aligned to the business objectives and results.
Freestream Solutions offers innovative solutions in the following areas:
Labeling (including structured authoring in SPL/PLR and PIM)
Pharmacovigilance
Clinical Trial Management
Product Development & Transfer
Project Management
Relevant Experience:
Top 15 Pharmaceutical Client: Managed the engagement to define and implement a consistent, compliant label generation process with clear “end-to-end” accountability and integrated change control across all stakeholders for the Consumer Healthcare Division (OTC).Implemented a formal labeling governance model to drive regulatory and medical decisions.Managed the review of all documentation that supports labeling in the U.S. to ensure consistency and accuracy (e.g., Master Batch Record, Formulation, Regulatory and Medical Claims, Regulatory Text, CFRs and Monographs, and Packaging Artwork)
Top 15 Pharmaceutical Client: Managed the effort to define a global vision for labeling content management using XML to support Structured Product Labeling (SPL) in the US and Product Information Management (PIM) in Europe. Managed the request for proposal (RFP) process to select a structured authoring tool, including defining requirements, authoring the RFP, managing the vendor demonstrations, and providing the analysis to identify the preferred vendor. Defined the initial implementation project and resource plan covering the entire software development lifecycle (SDLC).
Top 5 Pharmaceutical Client: Advised a client on the selection of a global pharmacovigilance system by recommending requirements to be used in a request for proposal (RFP) and evaluating a vendor response to the RFP. Defined the program to implement the pharmacovigilance system, including the project plan, resources, and program governance model for these areas: process and requirements definition, change management & organizational design, and training.
Top 20 Pharmaceutical Client: Managed the team responsible for redesign of global pharmacovigilance processes (case processing, expedited reporting, aggregate reporting, E2B, dictionary management, clinical reconciliation) for a large pharmaceutical company with 70 sites worldwide. Managed the definition of functional requirements for a global PV system to be implemented in 40 countries. Managed the development of user training materials.
Top 15 Pharmaceutical Client: Designed a global product labeling process with focus on core and affiliate labeling decisions, single document repository (for text, artwork, and specifications), electronic workflow, and batching of changes to minimize the impact to affiliates, local health authorities, and manufacturing plants. Defined and managed the system selection for an enterprise-wide labeling management system to control the end-to-end labeling and packaging process.
Top 20 Pharmaceutical Client: Managed the design of a division-wide cross-functional biological product development and transfer process spanning strategic research to launch, and implemented online product development tracking. Designed a new program management organization and redefined the product development governance process.
Top 20 Pharmaceutical Client: Managed the redesign of the process for validating manufacturing techniques, facilities, and equipment resulting in over 50% savings in cost and cycle time.
Top 15 Pharmaceutical Client: Transformed a clinical trial monitoring group into a more effective organization. Facilitated issue-based problem solving workshops with a senior advisory group and helped develop solutions for capacity management, strategic outsourcing, planning, performance management, and communications.