As a 501(e) member owned hospital services cooperative, New England Life Care (NELC) has built a 6,500 + sq ft. state-of-the-art 503B compounding facility in Woburn, MA to meet the needs of our members. We provide a cost competitive product, peace of mind knowing we set quality standards, unfettered access to all quality reports, and equity in the facility built with each order.
Team of Experts
Advanced Compounding Solutions has brought together a team of experts with a commitment to quality and safety.
- Grifols Engineering: a leading global healthcare company in facilities & engineering design (Conceptual & Detailed), GMP manufacturing process, project management, build & validation, inventory management & lean methodology
- LDT Health Solutions, Inc: specializing in medication safety, 503B Operations, site management, regulatory, QC /testing, P&P /training
- NELC: Business management, financing, real estate, logistics, customer service, pharmacy
Advanced Compounding Solutions stands out from other 503(b) facilities
Our facility has the most up to date licensure and FDA registration adhering to cGMP manufacturing processes and all current regulations. State of the art equipment ensures standardization of processes. Advanced Compounding Solutions has partnered with Baker to provide access to equipment that includes hoods with cameras to capture live images of our technicians compounding.
- Our real time monitoring with CIMScan software affords the ability to monitor and control temperature, pressure, humidity and particle count continuously.
- Environmental monitoring and trend studies will be done for each batch, endotoxicin for pathogens, liquid particulate matter, potency and pH to insure the facility maintains a controlled environment.
Teaming with ConsortiEX, we provide 503B specific software for ordering ease. Advanced Compounding Solutions will be the first company to provide documentation from clean room to administered patient dose.
Our dedicated Quality Management staff uses Celsis vs. USP Compedial Method microbiology sterility testing allowing for a rapid detection method. Batches are released in 4-7days using a laser measure with light vs. visual inspection taking 14 plus days. Stability studies are performed for all products to include container integrity.
We have you covered, in the event of power outage; our Kohler generator will keep our clean rooms operational under any circumstances.