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
