Our mission is to be the strategic operations partner that de-risks growth for medical technology and regulated-product companies.
We integrate rigorous project management, compliant design controls, and scalable business processes into a single, streamlined approach. This ensures your strategic vision is executed as planned, turning an idea into a state of the art medical technology, while expanding your business and clarifying operational complexity as you grow.
We guide your product through FDA and ISO-compliant design controls, turning regulatory complexity into a clear pathway from concept to market approval—so you can launch faster and with confidence.
We build and maintain the project management systems your team actually uses, keeping complex systems, formulations, software, and capital projects perfectly aligned, on time, and on budget.
We build scalable business processes for Operations, CRM, ERP, and Compliance such as complaints, nonconformances, or vendor management, transforming operational friction into clarity and efficiency as your company grows.
New systems fail without user adoption. We partner with your team to map workflows, overcome resistance, and simplify onboarding, ensuring your strategic changes stick and deliver value.
Lenin leverages 14+ years in MedTech and BioPharma to streamline programs, projects, and processes. As a Project Management Professional, he has designed and implemented project and program management solutions for small, midsize, and large companies. He specializes in implementing robust project management frameworks and processes that align with business objectives while fostering team collaboration and accountability.
His leadership spans product launches, regulatory submissions, change management and quality/process improvements. Lenin holds an active PMP certification from Project Management Institute, an MBA from Boston University and a BS in Molecular Biology from Montclair State University. Passionate about bridging science and strategy, he enables teams to accelerate therapies from bench to bedside.