Michelle Lott, Rac Email & Phone Number

Tucson, Arizona Area

𝗹𝗲𝗮𝗻𝗥𝗔𝗤𝗔 serves the medical device, pharmaceutical, biologics, cosmetics, and food industries, specializing in simple solutions to complex regulatory problems. We facilitate medical device development and compliance across the entire product lifecycle. 𝙔𝙤𝙪𝙧 𝙍𝙚𝙜𝙪𝙡𝙖𝙩𝙤𝙧𝙮 𝙎𝙩𝙧𝙖𝙩𝙚𝙜𝙮Your regulatory strategy defines the most direct path to achieve your project objectives. Let's maximize compliance, expedite product commercialization, and save you some time and money!𝙔𝙤𝙪𝙧 𝙍𝙚𝙜𝙪𝙡𝙖𝙩𝙤𝙧𝙮 𝙎𝙪𝙗𝙢𝙞𝙨𝙨𝙞𝙤𝙣𝙨Your 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.𝙔𝙤𝙪𝙧 𝘼𝙪𝙙𝙞𝙩 𝙋𝙧𝙚𝙥𝙖𝙧𝙖𝙩𝙞𝙤𝙣 𝙖𝙣𝙙 𝙍𝙚𝙢𝙚𝙙𝙞𝙖𝙩𝙞𝙤𝙣Your audit management processes 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, and responding to cited deficiencies: If it’s got the word “audit” in it, we’re your team.𝙔𝙤𝙪𝙧 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝙎𝙮𝙨𝙩𝙚𝙢𝙨 𝙖𝙣𝙙 𝘾𝙤𝙢𝙥𝙡𝙞𝙖𝙣𝙘𝙚Your 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.𝙔𝙤𝙪𝙧 𝘿𝙪𝙚 𝘿𝙞𝙡𝙞𝙜𝙚𝙣𝙘𝙚It 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.𝙔𝙤𝙪𝙧 𝙏𝙚𝙘𝙝𝙣𝙞𝙘𝙖𝙡 𝙎𝙪𝙥𝙥𝙤𝙧𝙩Your technical support is best delegated to my team – unless you enjoy staying current on every risk, usability, engineering, testing, reporting, and other protocols! Relax - we’ve got this.

Advisory Committees play a key role in FDA’s decision-making process by providing independent expert advice on extraordinarily complex issues. The DGMP advisory committee reviews proposed regulations for good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations on the feasibility and reasonableness of the proposed regulations. The industry representative on the advisory committee speaks on behalf of the interests and concerns of industry during FDA's evaluation process.

Cognition leverages Michelle's regulatory expertise in product commercialization to customize regulatory solutions and messaging throughout our software products. Michelle coaches and mentors both internal employees and external customers, helping all understand the changing regulatory environment and how tools like Cockpit help navigate product development.

Cleveland, Mississippi

Raps Executive Development Program

B.S., Chemistry

Major in Chemistry, Minor in Math