- Cell Therapy & Regenerative Medicine Services
- Commissioning
- Equipment Procurement
- Facilities Project Management
- Facility Programming
- Regulatory Services
- Research Animal Facilities and Protocols
- USP 797 Compliance Assistance
Cell Therapy & Regenerative Medicine Services
SOS provides a comprehensive hands-on approach to support manufacturing, testing, and process development for cutting edge products involving cell and gene therapies, tissue engineering/regenerative medicine products, and other advanced medical device biological therapeutic modalities. We work closely with clients to establish a customized plan, uniquely tailored for their specific needs and application at every stage of the process.
Our experts provide the full range of services to ensure robust quality systems are in place and regulatory requirements are fulfilled.
- Design and implement all aspects of quality systems
- Perform GxP (GLP, GTP, GMP, other cell/tissue accreditation bodies) assessments
- Execute third party external audits
- Write, review and edit SOP documentation, validation protocol, and IND/BLA applications
- Advise on process control, equipment selection and other facility design and operations aspects
- Recruit key personnel and establish training programs
- Consult on technology transfer, process development and analytical testing requirements
- Direct project management
Commissioning
Facilities designed for biomedical, pharmaceutical and other scientific related procedures have operating standards that are subject to a high level of scrutiny due to the nature of their business. The faster you can get into a functioning facility, the quicker you can get to the marketplace.
As your commissioning agent, we ensure that the constructed facility meets your needs, working quickly and efficiently to identify and resolve any issues that stand in the way. With a detailed approach and integrated involvement at every step in the design-build process, we develop a customized commissioning plan directly from the Basis of Design (BOD), ensuring that all of your critical needs are met.
SOS can facilitate open and clear communication between the design, engineering and construction team members throughout the life of the project, ensuring that the project proceeds according to your defined requirements and avoids the mistakes that lead to increased expense and delays. Through our comprehensive process, we test and evaluate the electrical systems, critical functions and design to ensure compliance with the operational requirements dictated by your specific operational needs.
ISO Certification
For facilities that require an ISO-certified operating standard, SOS can perform the entire ISO certification process following the successful completion of the commissioning effort.
Equipment Procurement
The sensitivity of your work requires the right tools to get your job done right. Through our extensive industry network, SOS can get you the equipment you need – with efficiency and reduced cost.
SOS has considerable experience locating and purchasing remanufactured and refurbished laboratory equipment – we can often locate the exact brand and model number you desire.
- Incubators and environmental chambers
- Biosafety cabinets
- Microscopes
- Cage & Rack Washers
- Ventilated Caging Systems
- Analytical and Support Equipment Of All Kinds
Facilities Project Management
No provider can build value like SOS when it comes to managing construction projects for research labs, cGTP or cGMP clinical and commercial manufacturing/processing facilities, cell and gene therapy facilities, and research animal care facilities. With a hands-on approach to every single detail, we will deliver your project on time and on budget.
On-Site Project Management – We are your representative on the work site. We allocate a project manager to oversee the details, provide quality control and enforce contract provisions and schedules.
Swift Conflict Resolution – The Request for Information process adds days to your construction schedule and costs to your budget. Our average turnaround time is 90 minutes from the detection of the problem to the publishing of an engineered solution. We have the expertise to find an appropriate solution on the spot – decisions are made immediately so the job never stops.
Lower-Cost Scope Changes – Change orders create escalating costs. Because we’re the experts in technical facility construction, we can find the best solution for the best price.
Facility Programming
SOS will work with you to plan your first facility or your next expansion project. Because we understand the science of drug discovery, we can build the facility you need to meet your goals as quickly as possible – letting you remain focused on your work to bring your product to the market ahead of the competition.
With an extensive background in product development, cGTP and cGMP manufacturing and animal care, we can evaluate and challenge your needs and will match your near-term and expansion plan budget to an appropriate floor plan. We’ll tell you upfront what it’s going to cost, and how long it will take to deliver.
There’s no hindsight or wasted effort – when the building is complete, you know it functions the way it should. Our staff actually operates discovery, development and manufacturing facilities, so everything is properly engineered. And because we understand the engineering, your initial costs are lower.
SOS supports the Programming Process
- Conduct user interviews to generate room data sheets
- Develop schematic design; generate equipment listing and basis of design document (BOD)
- Facilitate user reviews
- Update schematic design, equipment list and BOD
- Finalize schematic design, equipment list and BOD
- Develop program documents
- Adjust and publish program documents per user input
Regulatory Services
The regulation and compliance process for new products is rigorous. From pre-clinical studies to Title 21 compliance, a thorough and high-quality regulatory strategy demands expertise.
Working with SOS to develop and execute your regulatory strategy gives you access to more cost-effective services that fully support your management goals and maximize efforts related to medical product development, all while assuring Title 21 compliance.
Our experts will create a customized plan for your company or organization that ensures you get and pay for exactly what you need.
- Regulatory Strategy Planning and Submissions
- Pre-Clinical Research Programs
- Title 21 Support
- Medical Product Development Project Management
Research Animal Facilities and Protocols
SOS is an industry leader with a tradition of high performance, and nowhere is our advantage more evident than in the area of Research Animal Facilities and Protocols. We provide the leading-edge solutions to enhance your performance. Whether it’s through USDA and PHS compliance support or equipment procurement, SOS provides the expertise to help you build and maintain functional, efficient facilities.
Outsourcing the development and management of an animal care facility to SOS ensures you receive the services you need to work with animals safely and humanely while meeting your research goals. We can design, build and operate animal care facilities for all species. We provide safety training on equipment and help you establish an institutional animal care committee.
In short, we prepare you to conduct your research in a safe, professional environment.
- USDA Regulatory Process and PHS Assurance
- AAALAC Application Packages and Inspection Support
- IACUC Support
- Complete Operations Management
- Equipment Procurement
- Animal Study Protocols and SOP Development
- Support for Managing Inspections
USP 797 Compliance Assistance
SOS specializes in the development, construction and operation of facilities that meet complex regulatory standards. If your pharmacy dispenses compounded sterile preparations, your facility must be equipped to operate under the provisions of USP 797. SOS can help you achieve and maintain a compliant operation.
Our experts can help you ensure that the appropriate standards are met.
- Analyze dispensary plan to determine the need to conform to USP 797 provisions
- Develop and optimize space programming for new construction or renovation projects showing all engineering controls required for compliance
- Coordinate architectural and engineering design and provide complete equipment planning for USP 797 compliance and operation
- Assist with developing a Total Project Control Budget for required renovations or construction
- Coordinate the development of design/construction documents
- Provide comprehensive project management services
- Assist with problem solving for existing facilities that are not in compliance
- Provide commissioning, re-commissioning and ISO certification services