StrataBio Consulting LLC is dedicated to supporting biotechnology and pharmaceutical companies in navigating critical strategic decision, from drug development to commercialization. Our
tailored solutions
drive innovation and efficiency in analytical development, microbiology (safety) and GMP operations.
At StrataBio Consulting LLC, we provide tailored analytical development services designed to help you navigate the complexities of compendial and regulatory requirements. Our team works closely with clients to understand the specific guidelines and select the most efficient technologies, ensuring compliance while preserving valuable samples. From validating non-compendial methods in accordance with GMP standards to overseeing method transfers and selecting rapid microbiology techniques, we offer comprehensive solutions to streamline your analytical development programs and accelerate product timelines.
At StrataBio Consulting LLC, we specialize in the design and setup of compliant, cutting-edge laboratories, whether for facility expansions or upgrades. Our team brings extensive experience, guiding clients from project inception through to operational success. We help define the commercial or manufacturing goals of your laboratory, selecting the right technologies for each stage and identifying processes best suited for outsourcing. Our expertise ensures GMP compliance, operational efficiency, and robust environmental monitoring programs. From transitioning to GMP standards to implementing new technologies that enhance efficiency and automation, we’re here to build laboratories that meet the highest standards.
At StrataBio Consulting LLC, we understand that finding and managing the right external partners is crucial to the success of your company’s pipeline. Leveraging our firsthand service provider experience, we help clients select and oversee the right manufacturing, testing, and analytical partners. Our goal is to simplify the process, ensuring smooth and efficient collaborations that drive results and keep your projects on track.
StrataBio Consulting LLC was established to help companies achieve and surpass their commercial and business goals by offering expert, fit-for-phase and fit-for-purpose guidance—without the limitations of permanent executive roles. Our seasoned team provides precisely the support you need, acting as interim members of your leadership team, delivering expertise when it matters most.
Let's build solutions together, your next step starts here.
services@stratabioconsulting.com