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A Letter From The President

Typical Clients

Strategic Partners

Warren A. Opfer C. V.







Life Sciences Services International (LSSI) founded in 1992 is a regulatory compliance and information technology consulting business. We specialize in assisting pharmaceutical, medical device, biotech, and healthcare companies in the areas of IT, quality assurance, manufacturing, material control, and regulatory compliance.

Engagements have included activities such as:

  • Portfolio, Program, and Project Management
  • Strategic Planning
  • Risk-based Planning
  • Requirements Analysis, User and Functional Specifications
  • Workflow Analysis including Manufacturing Process Flow
  • Business Process Modeling and Re-engineering
  • Custom Systems and Database Design and Development
  • Software Quality Assurance
  • Vendor and Product Analysis
  • Computer System Validation (CSV)
  • CAPA and Adverse Event Reporting
  • FDA and Internal Audit Support and Responses
  • ERP, MRP, and Supply Chain Analysis
  • AIDC and RFID Technology
  • Capability Maturity Modeling (CMM)
  • Project Management Maturity Modeling (PM3)
  • Planning, Design, Development, Documentation, Deployment (PD4) Methodology
  • Agile Software Project Management and SCRUM
  • Lean and Six Sigma
  • Document and Knowledge Management

Our associates are highly experienced in the Chemistry, Manufacturing, and Controls (CMC) process, preparing Validation Master Plans (VMPs), Computer System Validation (CSV), 21 CFR Part 11, QSR 21 CFR 820, GxP, ICH, GAMP 5, and ISO 13485 and ISO 14971.

LSSI is incorporated in the State of Ohio. We are comprised of four principals and a wide variety of associates. We use a mixture of employees and consultants under contract, who are industry and technology specialists. The advantage of this approach is our ability to bring a large number of highly qualified professionals into a project team whose total focus is the client's satisfaction. In this way, we bring to our clients the finest talent and technology available while keeping our overhead down and our prices competitive.

LSSI has served clients in twenty-eight U.S. states, the District of Columbia, Puerto Rico, Canada, Dominican Republic, France, Germany, Italy, Mexico, and The Netherlands. We are proud of our track record of satisfied clients and look forward to continuing to serve a global clientele. We currently have operating locations in Dayton, OH; Baltimore, MD; Chicago, IL; Raleigh, NC; Milwaukee, WI, and San Diego, CA.

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