Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
Services
We offer product development consulting and services in combination products, life science tools, microfluidics and simulation & modeling. We have a large portfolio of accomplished projects. Our goal is to simplify and accelerate the product development.
Combination Products
We specialize in drug-device combination products for biologics, including infusion systems, on-body injectors, autoinjectors, pens, prefilled syringes, vials, and infusion bags.
Our comprehensive services span the entire product development lifecycle, offering expertise in design & development following strict design control processes, program management, technology selection, risk assessment, and preparation of regulatory submission documents.
We collaborate closely with biopharmaceutical and biotech companies to select the most suitable combination product for their drug. Our team ensures the proper management of Design History Files (DHF) and all required documentation for regulatory compliance.
We guarantee that all design verification and validation activities are executed in accordance with FDA regulations and ISO standards, ensuring your product meets the highest quality and safety benchmarks.
Our mission is to empower our clients with the knowledge and tools to accelerate the approval and successful launch of combination products. Visit our Knowledge Center to explore the process, and take advantage of our ready-to-use templates to jumpstart your development. These templates should customized to fit your specific biologic or drug product, and our team is ready to assist with the adaptation.
Refer to our Templates for combination Products. We have listed all the documents necessary for Design History File and you can reach out for templates on each section.
Product development: Life Science tools, BioSensors, Microfluidics
We bring extensive experience in the development of cutting-edge tools for life sciences, bioprocessing, biomanufacturing, and medical devices. Our team supports every stage of your project, from idea generation and prototyping to testing, characterization, modeling, and simulation.
Some of our successful projects include innovations in cell encapsulation using biocompatible hydrogels, high-throughput cell sorting and screening, biosensors, and live cell-based assays. We are also experts in microfluidic design, offering troubleshooting services, fluidic automation setups, and guidance on selecting the right fluidic components for your application.
Additionally, we provide support in manufacturing your devices, ensuring the highest level of precision and performance.
Modeling and Simulation
We offer advanced modeling and simulation services to support the design and optimization of your products. Our expertise includes finite element analysis (FEA) for structural, thermal, and mechanical simulations, computational fluid dynamics (CFD) for fluid flow and heat transfer analysis, and first-principles mathematical models to predict system behavior with precision.
These tools allow us to evaluate complex scenarios, troubleshoot issues, and optimize designs before physical prototyping, reducing development time and cost while ensuring high performance and reliability of your devices
