Singota Solutions offers GMP compliant labeling and kitting services alongside comprehensive storage and materials management solutions for a diverse range of client products, including API, excipients, consumables, and stability/retention samples. Our state-of-the-art facilities and certified staff ensure the safe handling and storage of hazardous materials, covering various categories such as flammable, toxic, and potent products. With environmental conditions ranging from controlled-room temperature to deep frozen storage (-80°C), our US and European locations provide flexible options to meet specific storage requirements. Our cold chain pharmaceutical storage capabilities are supported by experienced staff who ensure compliant transportation of temperature-sensitive products, while our logistics expertise facilitates domestic and global distribution. From clinical distribution to commercial 3PL management, Singota Solutions delivers tailored solutions to optimize distribution compliance and support regulatory requirements, including transportation simulation validation and import/export support for serialized products in accordance with DSCSA regulations.
September 2024 Supply Chain Metrics
99.7%
Right the first time Operations
100%
On-Time Shipments
99.7%
Excursion Free Shipments
99.7%
Right the first time Operations
100%
On-Time Shipments
99.7%
Excursion Free Shipments
September 2024
Capabilities and Services
Supply Chain Overview
Materials Management (receipt, storage, shipment)
We manage a range of materials from APIs and raw materials to finished products. We have the capability to handle toxic, potent, flammable, and hazardous materials. Our secure, cGMP warehouse utilizes ICH storage conditions including controlled room temperature (15-25°C), 2-8°C, -20°C, and -80°C. We also provide distribution of clinical trial materials, as well as temperature controlled shipping for temperature sensitive products.
Sampling and Dispensing
Singota can aliquot materials from bulk to specified weights or volumes into appropriate containers for testing, development, and manufacturing purposes. These operations are performed in our designated cleanrooms under ISO 8 conditions.
Cold Chain Solutions
Our cold chain experts have the experience and knowledge to manage temperature sensitive materials throughout the distribution process. We offer pharma cold chain services to our clients in both upfront design and execution phases.
- Design services include packaging recommendations, cold chain design and mapping, and shipper qualification services (thermal and mechanical).
- Pharma cold chain management services include GMP compliant warehouse storage with validated thermal monitoring systems, cold chain pharmaceutical storage, procedures for proper shipper pack-out, in-transit temperature recording, time out of refrigeration (TOR) monitoring, and arrangement of domestic and worldwide material distribution under controlled temperature conditions.
Transportation Simulation Laboratory
The Transportation Simulation Laboratory (TSL) is located at Singota’s facility in Bloomington, Indiana and consists of a large environmental champer equipped with a control system, calibrated sensors, and a validated data collection system with mechanical and hydraulic equipment that can simulate a customized distribution environment profile. Environmental hazards in transport that can be applied include:
Humidity Temperature Pressure Shock Vibration
Learn more about our Transportation Simulation Testing HERE.
International Supply Chain Management
Clients can take advantage of Singota’s designated European depot for International storage and dispensing services. Clients of Singota can store materials in our approved partner’s bonded warehouse at storage conditions including 15-25°C, 2-8°C, -20°C, or -80°C. Importer of Record (IOR) assistance is also available for clients.
Learn More About Supply Chain
Additional Support
Singota provides 24/7 client access to material transaction history and current material inventory status through our unique E-Transparency system. Using this web-based portal, clients can manage their inventory and make requests for services such as sampling and shipping. Each client has a dedicated project manager at Singota. Project managers work closely with the project team and our clients to help create customized solutions and ensure projects are completed on time. As with all of our service lines, we pride ourselves on being agile, accountable, and transparent. See how we’re performing—view our current metrics for supply chains in the pharmaceutical industry on Right the First Time Operations, On-Time Shipments, and Excursion Free Shipments.
