Our Clients

We Help Companies at Every Stage


Startup

New to the market with limited regulatory, quality, or marketing resources or experience.

  • Customer feedback and regulatory guidance to finalize development

  • Quality System development and audit preparation

  • Understand the regulatory pathway and criteria for approval

  • Estimate budget for clinical study and submission

  • Identify study sites, manage studies and regulatory submission

Growth

A growing portfolio demands greater regulatory expertise and quality system expectations grow.

  • Manage regulatory strategy and clinical studies to expand product portfolio

  • Expand claims for existing products

  • GAP analysis and CAPA implementation for current QMS

  • Go-to-Market strategy and support

Established

Support existing teams with subject matter experts and implementation support.

  • Manage regulatory strategy and clinical studies to expand product portfolio

  • Expand claims for existing products

  • GAP analysis and CAPA implementation for current QMS

  • Go-to-Market strategy and support

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