7318 S. Revere Parkway, Unit B5, Centennial, CO 80112 
720 981-1622
inquiry@tglabs.com

​the methods we use

We inn​ovate


Most 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. 

proven PRODUCTION and R&D methods


Project Management:

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).


Protocol Development:

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. 


Process Design, Analysis and Documentation:

TG Labs designs processes for scalable manufacturing and conducts scaling studies. Our designs are scalable and reproducible and adhere to GMP and FDA regulations. 


Production:

LEAN

Six Sigma


Product Development:

SEIT for engineering and design

Project flow Stage Gate process​


Analytics and Testing:
Our technical team conducts tests throughout the production process to ensure that your end product meets both your requirements as well as the FDA and industry standards. 


Regulatory:

Quality Management System (QMS)

GMP

​FDA MoCRA 2022

FDA & CE Marking


Employee Training:
Each employee is trained to our Quality Management System (QMS) and we conduct annual refresher training to ensure adherence to GMP and FDA regulations.


Design:
Analysis; chemical process; PC board design; electronics integration; integrated circuit programming; plastic injection part design; human factors; controls; telemetry; SCADA; mechanical design; electrical design; design for manufacturability; P&ID.


Eng​ineering:
Chemical analysis; chemical process; mass balance; materials development; custom protocols; validation work; product testing; microbial and stability testing.


Research:
Basic materials; advanced materials; chemical reactions; computational fluid dynamics; finite element analysis; custom research projects; scientific studies (chemical/materials/function); failure analysis; cleaning validation; sterile validation.


TG Labs / Client Communication During Projects:
We collaborate and communicate with clients on projects using a tool called Basecamp. Basecamp is a web-based project-management tool that offers to-do lists, wiki-style web-based text documents, milestone management, file sharing, time tracking, and a messaging system.