Most engineering designs need to be realized in a manufacturing environment. TG Labs' experience and expertise in research, design and manufacturing ensures your project meets specifications in accordance with GMP standards and FDA regulations.
Organizations need to be flexible and nimble to exceed the competitive demands of the ever changing market place. Our team strives to create an environment where you can realize your concepts, thereby outsmarting your competition and increasing your bottom line.
We create an environment where creativity and innovation within the sciences is employed and production is optimized. We accomplish this by applying multiple disciplines that bring you a comprehensive team to serve your required needs.
Projects need to be managed and delivered on time and within budget. We manage key attributes of your project through a statement of need, concept of operations, architecture (internal and external), high level requirement's list, detailed requirements, risk analysis, traceability, test design & testing and creation of document-history/device-history records. This system is called SEIT (Systems, Engineering, Integration and Test).
Specialized chemical processes require protocol development. TG Labs uses proven methods to create protocols that reduce complexity and help workers meet specifications and requirements of test and method. We have developed protocols in the chemical, biochemical, material science and life science sectors.
TG Labs designs processes for scalable manufacturing and conducts scaling studies. Our designs are scalable and reproducible and adhere to GMP and FDA regulations.
SEIT for engineering and design
Project flow Stage Gate process
Quality Management System (QMS)
FDA MoCRA 2022
FDA & CE Marking