Your regulatory strategy defines the most direct path to achieve your project objectives. Together, let’s maximize compliance, expedite product commercialisation, and save you time and money!Learn More
Your regulatory submissions are too important for anything shy of the most thorough examination for completeness and accuracy.
While we’re at it, let’s clearly demonstrate safety, efficacy, and regulatory compliance so your product can be cleared for market quickly and efficiently.Learn More
Quality Systems and
Your quality system should be scaled to the size, activity, and requirements for your company.
That way, we can focus on product safety outcomes and be ready to respond rapidly in the unlikely event of crisis.Learn More
Your audit management can make the difference between a clean bill of health and a 483, warning letter, or worse.
Preparing for audits, conducting internal and supplier audits, managing an audit when FDA knocks on your door: If it’s got the word “audit” in it, we’re your team.Learn More
Your due diligence starts with a product pathway assessment and an extensive review of your documentation.
We do these to mitigate your liabilities and risks because you surely don’t need any costly remediation in your life.Learn More
Your technical support is best delegated to the Lean RAQA team. That is, unless you enjoy staying current on every risk, usability, engineering, testing, reporting, and other protocols! We’ve got this.
You go on and focus on winning in the market.Learn More
Your grief counseling
Part of my job is, you guessed it, grief counseling, because dealing with regulators can be emotionally draining.
I’ll help you arrive at grief stage five (acceptance) quicker because you’ll have a steady hand at your side at all times.