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Project Management, Production,

Quality and Other Technical Services

 
Partners LLC: Biomedical Consulting

 

Project Management

With nearly two decades of experience in corporate project management, LSP is well-qualified to assist in defining and assembling the elements needed for an effective project team and execution strategy, and to help with follow-through and periodic assessments of progress.

  • Define the project and create the mission statement

  • Identify major project goals

  • Identify, define and prioritize tasks

  • Identify and optimize critical path

  • Analyze strengths, weaknesses opportunities and threats (SWOT)

  • Define achievement milestones and metrics for performance assessment

  • Construct Gantt charts (time lines) for project tracking

  • Identify internal core competencies and resource constraints

  • Define achievable internal resource allocation

  • Outsourcing vs. internal assignment of specific functions

  • Assess and select external service providers

  • Supervise and manage performance of contract firms

  • Set up and execute progress monitoring function

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Manufacturing and Quality

The success of LSPís principals in establishing quality systems and in overseeing product development leading to cGMP drug production, well qualifies us to assist with your quality and production needs.

  • Qualify and select contract testing laboratories and production facilities

  • Assist with facility design and process development

  • Develop test methods and final product specifications

  • Design stability testing programs; select test parameters

  • Structure corporate quality system

  • Assess compliance with current Good Manufacturing Practices (cGMP; for drugs) and Quality System Regulation (device)

  • Provide on-site instruction in cGMP- and ICH-compliant systems and practices

  • Assist with inspections by FDA, the Nuclear Regulatory Commission (NRC) or foreign regulatory agencies

  • Review or prepare validation protocols and reports

  • Review or prepare standard operating procedures (SOPs)

Other Services

With thirty years of experience formulating searches of technical and biomedical databases, LSP can provide efficient and effective literature and patent searches, and can also prepare review papers based on the search results.

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