Life Sciences projects are complex in nature and close collaboration between the Client and the Design Firm are essential for successful execution. Design Group, cognizant of the required association, assures the client’s needs are understood and implemented accordingly. We cultivate close relationships with our clients and select the overall best approach for project success while providing a completely confidential service. Our core expertise includes the design of facilities, process systems, piping, instrumentation, control system integration, packaging solutions and CQV services. One team providing “Total Operations Solutions for Industry”.
|Design Group is comprised of an integrated team of design professionals and technical specialists with extensive backgrounds in Biotechnology, Pharmaceutical, Consumer Healthcare and Medical Device facility design. Founded in 1986, Design Group provides solutions ranging from conceptual planning and capital budgeting of future initiatives, to full service EPCMV (engineering, procurement, construction management, and validation) solutions to the life sciences industry. We are focused on delivering engineered solutions to your most challenging business needs.
Medical Device Solutions
Design Group is uncompromising with respect to quality, confidentiality and safety. We focus on developing long-term client relationships through proven execution. We recognize that requirements frequently change throughout the project life cycle, and adapting to change is a core strength of the firm. Our goal is to provide maximum value for your investment.
Our engineers, architects and designers are experienced in a wide range of processing technologies, which are at the foundation of the Life Sciences Industry. Process Engineers, working closely with our Process Architects, Piping Designers, Facility Engineers, Control System Integration Team and Regulatory Compliance professionals are capable of efficiently translating the client’s needs into an optimum manufacturing process and facility design in compliance with all applicable cGMPs, codes, regulations and standards governing the industry.
Our professionals, in concert with our clients, work conjointly to develop science based approaches with strict attention to mitigating risk while adhering to the latest FDA and ICH guidelines. We strategically target critical process parameters with a focused determination on the client’s investment.
Our consulting services include:
- Constructability Assessments
- Site/Facilities Master Planning
- Integrated Project Delivery Concepts
- Feasibility studies & URS Development
- Conceptual Design & Project Program Development
- Due Diligence & Condition Assessment
- Benchmarking & cGMP GAP Analysis
- Program & Project Management
- Product Life Cycle Management
- Process Simulation/Optimization
- Continuous Manufacturing Process Technology
- Manufacturing Intelligence
- Basis of Design Reports - BOD
- Detailed Design Drawings & Specifications
- Value engineering & Cost estimating
- Innovative Procurement Methods and Strategies
- Construction Management
- Controls System Integration & Automation Design
- Commissioning, Qualification & Validation
- Regulatory Compliance
- Site Remediation
- Fill Finish and Packaging Facility Design
- Serialization, RFID
- Packaging Consolidation/Reconfiguration
- Clean Utilities
- Upstream and Downstream Process System Design
- Oral Solid Dosage and Liquid Manufacturing
- Single Use Systems