Our team of international technical and operational experts apply the latest technologies and methodologies to design, construct, and validate technically complex medical devices and novel dosage facilities.
We work closely with our clients to produce optimal facility layouts and specify equipment that works for unique production needs while meeting the latest global regulatory requirements.
Having worked with many of the leading medical device and novel dosage manufacturers, we have successfully completed projects for
- Packaging lines and systems
- Research and development facilities
- Manufacturing facilities
- Product development
- Utility generation and distribution systems
- Warehousing areas
Medical Device & Diagnostics Specialties
Our long history has given us the insight to streamline the production process for existing devices and to develop optimized solutions for new products on the horizon.
Our experts have the vast knowledge history to design a facility that will meet the production needs for diagnostic devices. From concept through validation, we guide our clients to manufacture the best available product.
Our services have included the validation of in-vitro diagnostic devices, the design of contact lens production lines and the delivery of state-of-the-art clean rooms for sensitive electronic devices.
We use expert knowledge to design sterile facilities to fill and finish inhalants and hold the related gases.
We have designed, built, and validated facilities that produce inhalants and inhalant delivery devices using the current methods in aseptic processing and sterilization.
We rely on expert knowledge to design and build systems for medical and pharmaceutical gases that comply with regulatory sampling and testing requirements.
The advent of pharmaceutical and medical gases indicates that there are increased opportunities for its use and further scrutiny from governing regulatory bodies. Our experts can inspect your facility or production area to ensure storage tanks and holding chambers are properly warehoused and their delivery devices are safe to use.
Polymers & Biomaterials
We understand the physical characteristics, manufacturing processes, and quality parameters associated with specialty polymers and biomaterials.
We apply our expert knowledge in organic and mixed materials to advance the development of our clients’ tissue culture, drug delivery, and medical device products. Our work with these highly specialized materials has given our clients the competitive advantage necessary for success. We understand the costs and benefits of industry standard delivery types.
Transdermal drug delivery has become an appealing alternative to oral delivery of low-dose drugs. As the popularity continues to grow, clients are finding new ways of delivering these therapies. We provide the knowledge and skill to design research and development labs and its supporting functions for them to find the path forward to delivering these therapies. The method of the drug delivery provides unique challenges when designing equipment and facilities because absorptions through the skin can occur inadvertently. The safe guards to prevent exposure is unique.
The manufacturing process of the primary container is more similar to a packaging operation, this causes a challenge when attempting to process the drug in an aseptic environment. Primary use for these type of delivery systems has been with the food and health care industry but a trend toward use in the medical and biotech industry has slowly been growing. It is an area of growth in the future due to the ease of delivery and introduction of the drug into the patients system.
Our global connections with equipment manufacturers enables us to get best-in-class equipment to our clients at the best price. From dermal patches to thermal ablation devices, our broad experience ensures the best results.
Using our expert experience, we design and engineer facilities and processes to allow our clients to develop new ways of transmucosal delivery. Our extensive work with clients has allowed them to refine delivery methods such as mucoadhesion, nasal sprays, and quick-dissolve tablets.
The manufacturing process of the primary container is more similar to a packaging operation, this causes a challenge when attempting to process the drug in an aseptic environment. Primary use for these type of delivery systems has been with the food and health care industry but a trend toward use in the medical and bio-tech industry has slowly been grow. It is an area of growth in the future due to the ease of delivery and introduction of the drug into the patients system.
Featured Medical Device & Diagnostics Experts
Jason S. Collins, AIA
Director of Process Architecture
Director of Architecture EMEA
Brian J. Egan, RA, LEED AP
Director, Process Architecture
Sr. Director Global Strategy & Technology
Leonard F. Pauzer
Director Drug Product Technologies
Director, Process Technology