At our BioTech/MedTech consulting firm, we specialize in supporting early and growth-stage companies with the guidance needed in one stage or throughout the process from concept to commercialization. Our team is readily available to identify, prioritize, and support your specific needs. Thank you for choosing our site and we look forward to helping you achieve success.

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Our Services

Explore Our Programs

We specialize in developing scientific, regulatory, and technical solutions for our clients in the life sciences and medical device industries.

Regulatory Consulting

  • US Regulatory Pathway Consultation

  • Medical Device Pre-submission assistance

  • 510(k) Submission assistance

  • Regulatory Compliance Reviews

  • QMS implementation

  • Independent QMS internal audit – ISO13485 & FDA Quality System Regulation

  • Regulatory Reporting and Documentation Preparation

  • Risk Assessment and Management Advice

  • Process Optimization for Regulatory Requirements

Scientific Contents Creation

  • Manuscript writing, editing, consultation, and review
  • Posters, white papers, articles&blog posts, social media
  • Figures, graphic abstracts, and slide decks
  • Grant proposal editing, and review
  • SOP writing, editing, and review
  • Technical documentation (e.g. User guide, IFU instructions for use, MSDS, etc.)

Startup Advisory

  • Business Model Development
  • Investor Readiness Advisory
  • Market Size Research
  • Development of executive summary, elevator pitch, and other initial documents
  • Pitch presentation development
  • Business plan creation, review, and/or enhancement
  • Refined Presentations and Strategic Investment Advice

BioTech & MedTech Commercialization

  • Competitive Market Analysis
  • Strategic Partnership & Market validation
  • Unmet Needs Assessment
  • Product Forecasting and Opportunity Sizing
  • Pricing, Reimbursement, and Market Access Analysis
  • Competitive Differentiation Strategies

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