Truesdale Regulatory Consulting LLC

Board certified regulatory affairs professional in the health care product sector and well versed in laws, regulations and guidelines related to product development and its associated framework that considers medical devices, pharmaceuticals, digital health, wearables and consumer products. I have direct liaison experience with US FDA and international regulatory authorities. My expertise in Regulatory, Clinical and Quality functions provides an effective platform to drive business enterprise efforts toward new product development, product acquisition, licensing and commercialization. My platform accommodates the full range of commercial phases including startup, scale-up, growth and company maturation. My influencing approach is to lead by example and create collaborative cross-functional team environments that facilitate high achievement; leveraging a diverse pool of knowledge assets and talent. All executed with an awareness of value creation. Areas of Expertise and Support: • Global regulatory strategy and agency negotiation • Leadership and talent management • Product development, labeling, advertising and promotion • Current Good Manufacturing Practices (cGMP) guidelines • Clinical trial operations • Complaint handling and vigilance • FDA Medical Device submissions: 510(k), PMA, HDE and IDE • FDA Pharmaceutical submissions: NDA/supplements • FDA Regulated Tobacco Alternatives (e.g. Vapor products): PMTA • EU Medical Device Regulation and CE Marking • International product registrations • Software as a Medical Device (SaMD) | Digital Health • Software embedded Electromechanical Medical Devices (SiMD)

• Employees 1