SERVICES

We offer a host of strategic, business, and biomedical solutions.

BUSINESS DEVELOPMENT SOLUTIONS

• Advisory, strategic and management services
  
• Due Diligence: Conduct industry analysis, competitive intelligence, market analysis, SWOT analysis, intellectual property overview
  
• Business Plan: Develop non-confidential executive summary, 15-30 page plan, 5-10 illustrations (includes tables, graphs, and figures), Microsoft Project cost-loaded timeline, appendices
• Investor Presentation: Develop 20-35 slide Power Point presentation with graphics, prepare and submit applications to different venture funds
  
• Financial Modeling: Develop Excel file with multiple spreadsheets, pro-forma financial statements, detailed assumptions, capitalization table, and company valuation
  
• Company Formation: Develop and implement formation of company
• Company Location: Identify office space, incubators, wet laboratory and/or animal vivarium space for rent or lease; manage contract and transition
  

BIOMEDICAL SOLUTIONS

• INTERACT, Pre-IND, and IND Preparation and Submission
  
• Clinical Protocol Development: draft clinical protocol with Principal Investigator
  
• Preclinical Data Package: Develop preclinical IND-enabling data packages to support clinical testing for gene and cell therapy therapy applications
  
• Laboratory Design and Build-out: Manage GMP/GLP/clean room lab design, BSL2/3 lab design, estimates, general contractor or construction company selection, validation, and project management through completion
  
• Conduct GLP laboratory set-up, SOP development, SOP training, equipment purchase, toxicology protocol evaluation, and/or cGLP vendor selection
  
• Manufacturing: Conduct cGMP vendor selection, contract execution, and product and document delivery
  
• Quality Assurance and Control: Serve as QA to ensure quality data and overall company and program compliance; conduct internal and vendor audits reports for cGMP, cGLP, and cGCP laboratories
  
• Establishment of Quality Documents
  
• Selection and implementation of electronic quality management systems