Support Services

MDS provides a full complement of support services critical to a complete and successful manufacturing project, including:

• Regulatory Support
• Project Management
• Analytics
• QA/QC

Regulatory Support
Every stage of the drug development has regulatory implications. MDS offers consulting services for assisting clients throughout pre-IND meetings and meeting packages as well as clinical trials and chemistry manufacturing and controls (CMC) activities. Read more

QA/QC
All of our manufacturing and support operations are built on the framework of a comprehensive quality system. Our services are designed to ensure client's operational excellence across their organization. MDS Capabilities include:

• Environmental and utility monitoring
• Raw material testing
• Ability to perform in-process and release assays in-house or manage external testing
• Stability studies
• Validation
• Batch Release

Analytical Development & Validation
MDS develops product-specific analytical methods to support clients' production processes as well as research and regulatory requirements. MDS will transfer in any existing client methods or develop methods de novo, including qualification and validation. Our services and methods include testing for product/process related impurities and developing release and in-process assays in support of cell culture and purification development employing a variety of methods such as:

• BCA /Bradford protein assays
• A280 protein determination
• UV-Visible spectral scanning
• pH
• Fluorescent activity assays
• ELISA assays
• HPLC -affinity,IEX,HIC,SEC,reverse phase
• SDS-PAGE analysis
• IEF analysis
• Western blot analysis
• LAL Endotoxin assays
• Bioburden determination

Project Management
MDS offers professional project management for our clients' with primary motivations in outsourcing. To execute the job well, we analyze every project's needs, develop a comprehensive plan and project map to optimize operation in our client's required timeframe, and methodically execute the plan with a constant view to the end state. We welcome your "person-in-plant" to assist you in developing the know-how required to support your product through clinical development and market launch.