Services
Frogmore's mission is to help your company develop the strategic services required to meet the business challenges of today, as well as the needs of tomorrow.
Frogmore delivers customized methodologies and logistics that have helped our clients achieve both growth and competitive advantage. From conceptualization and inauguration of initiatives to realizing and commercializing innovation, Frogmore facilitates collaboration across divergent sectors to ensure successful outcomes for life sciences projects, biotechnology companies and other technical entities.
New Product (Assay) Development
Providing a phased approach to in vitro diagonostic (IVD) solutions for the development cycle of new (or existing) products for rapid, point-of-care diagnostic systems using a variety of platforms. Comprehensive knowledge base for technology transfer from concept design to manufacturing, providing critical support by augmenting your team or standalone services in your facility. Custom designed program to specifically meet your project requirements. Special diagnostic interests in infectious human disease, neglected third world diseases, aquaculture, and environmental diagnostics.
- Concept-to-Final Package
- Feasibility
- Platform development
- Reagent development
- Stability testing
- Transfer to manufacturing
- Multiple platforms
- ELISA
- Immunochromatographic test (ICT)/lateral flow
- Dip-stick
Case Study
Eighteen years of experience in the research and development of diagnostic assays for environmental, food and human markets. Result: Twelve successful concept-to-market products still active in today’s marketplace.
Pre-Project Due Diligence
Scientific due diligence and valuation services to avoid costly mistakes, with a focus on customizing the development process and securing potential investment viability. Apply in-depth knowledge and experience with all phases of product development to identify the client’s assets as well as potential project issues.
- Competitor product evaluation
- Intellectual property/patent searches
- Literature searches
- Product feasibility analysis
Case Study
Performed comprehensive pre-project feasibility studies including intellectual property/patent searches, market research, competitor evaluations, manufacturing feasibility, and literature searches for twelve successful concept-to-market products. Result: All products continue to perform well in their respective markets.
Independent Project Analysis
A comprehensive and objective assessment of project viability, using internal and external research. Data is gathered via interviews, evaluation of project records, visits to design and manufacturing operations, and secondary research. Facilitates the team to shape its mission statement, evaluate the challenges of its product development strategy, and understand the company's current situation and strategy.
- Total Project Assessment
- Data Review
- Document Review
- Root Cause Analysis (RCA)
Case Study
Created a root cause analysis training presentation for a Maryland company that develops and manufactures immunochromatographic test (ICT) devices – lateral flow and dipstick. The instructional material included actual and theoretical scientific principles on the mechanics of ICT design and development, trouble-shooting problematic devices, and actual hands-on experimental guidelines. Result: A better educated development team that was able to quickly resolve its ICT issues.
Design of Experiments
Apply detailed Design of Experiments (DOE) analysis to the relationship between key input factors and process response. Provide detailed guidance through the experimental process, resulting in a more proficient future analysis. Results include maximization of experimental parameters, and optimization and control of the experiment or process.
- Identification of experimental goals
- Generation of a design matrix best suited to the experimental objective
- Statistical analysis based on experimental results
- Non-biased interpretation of results in realistic terms
Case Study
Studied time-dependent optimization of manufacturing conditions of critical reagents. Designed and implemented a longitudinal study for the production and stability of novel reagents that were key components to a human respiratory diagnostic assay. The analysis identified several important reagent parameters that were significant variables in the success of the overall project. Result: FDA approved product with increased sensitivity and specificity, and a minimum two-year shelf life expiration date.
Manufacturing Process Assessment
On-site analysis using Manufacturing Quality Surveillance (MQS) to define, automate, and optimize processes. Process standardization allows lessons learned and best practices to be used by the full team, providing reproducibility and reducing errors moving forward. Provides a valuable opportunity to develop and improve manufacturing, quality systems, and support processes.
- Material sourcing
- Process planning
- Process evaluation
- Process equipment design
Case Study
Managed the design, development, and implementation of a semi-automated manufacturing process to replace a manual assembly line for a Maryland-based environmental test manufacturer. Result: Manufacturing goals achieved to meet market demands; process continues to be cost-effective and productive.
Project Management for the Life Sciences
Direction and coordination of all phases of the project lifecycle: concept definition, feasibility study, design and development, transfer-to-manufacturing, validation, and release-to-market. Proficient in coordinating and scheduling, efficient decision-making, and accountability to stakeholders – all of which minimizes project delays and cost overruns.
- Project strategy planning
- Scope definition
- Time and cost management
- Risk assessment
- Communication
Case Study
Eighteen years of successful project management collaborations across the US and in Europe. Every project has included review and analysis (R&A) of current design protocols, consolidation and qualification of vendors, and negotiation with outsourcing vendors – all of which resulted in project cost savings, system-wide standardization and improved operational efficiencies. Effective implementation of project management tools to ensure that scope, schedule, communication, budget, risk assessment, regulatory compliance, and other stakeholder requirements were met at each phase (concept, design, feasibility, manufacturing and launch) of multiple projects.
Logistical Support
Design and implement a strategy for planning, developing, acquiring, and sustaining well-defined, affordable support plans that meet project requirements throughout the life cycle. Provide assistance and advice that meet specific client needs regarding collaborators, outsourcing, procurement, and vendor identification.
Case Study
Worked in partnership with physician researchers from leading medical schools in the development of two separate human diagnostic reagents. Result: Successfully developed reagents, which led to further research and development efforts for a rapid diagnostic assay to detect both pathogens.
Grant Liaison and Management
Act as primary contact between grantee and grantor. Submit grant applications, supervise grant application progress, review grant agreements, monitor grantee compliance, submit appropriate progress reports, file funding requests, and maintain a database/file system.
Case Study
Successfully managed a National Institutes of Health (NIH) and United States Department of Agriculture (USDA) grant for a Maine-based biotechnology startup. Monitored all aspects of both NIH/SBIR Phase I and USDA/CRIS grants for development of unique diagnostic reagents for the identification of a degenerative central nervous system disease. Result: Both grant phases were successfully completed and compliant with grantor requirements.
Quality Management System
Implements an internal and fully integrated Quality Management System (QMS) that meets your requirements and also becomes the foundation for future regulatory agency acceptance. Includes a document management system that connects the lifecycle of a product or process from research to feasibility to manufacturing and beyond. Allows for the collaboration and exchange of information among corporate management, R&D, manufacturing, quality assurance, and all employees
- Audits
- Documentation
- Corrective and Preventative Actions (CAPA)
- Design History File (DHF)
- Quality Manual
- Standard Operational Procedures (SOPs)
- Training
- Vendor Qualification (RFI/RFP)
- Verification and Validation Projects
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Custom Services
As an additional resource to its clients, Frogmore offers a range of client-specific services tailored to meet your unique needs.