Expectations of regulators, sponsors, and investors are met through efficient and well-designed quality systems and the implementation of a suitable development-stage. Several firms have unique requirements that are optimally managed through tailored quality systems and standard operating procedures. DSI develops or reviews Quality Management Systems to guarantee compliance for a firm’s current stage of operation.
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Pharmaceutical quality management
Compliance to current Good Manufacturing Practices (cGMPs) is vital for businesses and patients, and is an expectation of the Food and Drug Administration. Current pharmaceutical and medical device manufacturing is complex and needs high levels of experience in GMPs to guarantee compliance.
It is important to make sure your Contract Manufacturing Organization (CMO) or Contract Laboratory Organization (CLO) meets or exceeds FDA regulations in today’s highly regulated environment. To fulfill the FDA’s requirements under 21 CFR parts 210, 211, 820, and 11, firms need to have robust quality systems and processes, and a distinct supplier qualification process. DSI has the knowledge and industry experience to complete and manage these processes for any organization.
DSI: Your reliable partner for pharmaceutical quality systems
DSI has the ability to work with companies to ensure all processes are compliant by completing a Quality Gap Analysis or independent GMP audits. Whether a firm faces challenges with manufacturing, packaging, aseptic processing, laboratory research, labeling, validation, Standard Operating Procedures (SOPs), training, corrective and preventive actions, product adulteration, storage for raw materials, risk management, or other quality problems, DSI has GMP services that will offer the quality operations and systems, alongside the manufacturing expertise needed to aid companies in success.
DSI’s Quality Gap Analysis professionals spend a large amount of time on-site at the facility of firms, investigating all areas of the quality systems and manufacturing operations. DSI works with organizations and reviews the following:
- Personnel qualification and staffing
- Quality manual
- Change control
- Document management
- Electronic quality management systems
- Process validation
- Cleaning validation
- Equipment qualification and validation
- Manufacturing batch records
- Packaging batch records
- Part 11 compliance
- Analytical method validation
- Supplier qualification program
- Internal audit program
- Raw material testing and controls
- Environmental monitoring
- Inventory management
About DS InPharmatics LLC
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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