Michelle Lott

leanRAQA

Since 2010, Michelle’s ๐—น๐—ฒ๐—ฎ๐—ป ๐—ฅ๐—”๐—ค๐—” company has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services, and grief counseling โ€“ because dealing with regulators can be emotionally draining.

She writes, “Why not delegate all those things to me, so you can focus on winning in the marketplace.

๐•๐• ๐•ฆ๐•ฃ โ„๐•–๐•˜๐•ฆ๐•๐•’๐•ฅ๐• ๐•ฃ๐•ช ๐•Š๐•ฅ๐•ฃ๐•’๐•ฅ๐•–๐•˜๐•ช
Your regulatory strategy defines the most direct path to achieve your project objectives. Together, let’s maximize compliance, expedite product commercialization, and save you time and money!

๐•๐• ๐•ฆ๐•ฃ โ„๐•–๐•˜๐•ฆ๐•๐•’๐•ฅ๐• ๐•ฃ๐•ช ๐•Š๐•ฆ๐•“๐•ž๐•š๐•ค๐•ค๐•š๐• ๐•Ÿ๐•ค
Your regulatory submissions are too important for anything shy of the most thorough examination for completeness and accuracy. While we’re at it, letโ€™s clearly demonstrate safety, efficacy, and regulatory compliance so your product can be cleared for market quickly and efficiently.

๐•๐• ๐•ฆ๐•ฃ โ„š๐•ฆ๐•’๐•๐•š๐•ฅ๐•ช ๐•Š๐•ช๐•ค๐•ฅ๐•–๐•ž๐•ค ๐•’๐•Ÿ๐•• โ„‚๐• ๐•ž๐•ก๐•๐•š๐•’๐•Ÿ๐•”๐•–
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.

๐•๐• ๐•ฆ๐•ฃ ๐”ป๐•ฆ๐•– ๐”ป๐•š๐•๐•š๐•˜๐•–๐•Ÿ๐•”๐•–
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.

๐•๐• ๐•ฆ๐•ฃ ๐•‹๐•–๐•”๐•™๐•Ÿ๐•š๐•”๐•’๐• ๐•Š๐•ฆ๐•ก๐•ก๐• ๐•ฃ๐•ฅ
Your technical support is best delegated to the lean RAQA team โ€“ unless you enjoy staying current on every risk, usability, engineering, testing, reporting, and other protocols! Weโ€™ve got this.

๐—น๐—ฒ๐—ฎ๐—ป ๐—ฅ๐—”๐—ค๐—” serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.

๐—™๐˜‚๐—ป ๐—ณ๐—ฎ๐—ฐ๐˜๐˜€: I serve on the FDA Device Good Manufacturing Practices Advisory Committee and have a weakness for tequila and anything barbecued.”