704 South Na Wa Ta Avenue, Mount Prospect, IL 60056
CGMP Medical Consultants is a specialty planning and consulting firm for supporting research and development in the fields of biotechnology, pharmaceuticals, vaccine development, biologics, nanotechnology, and regulatory compliance. We specialize in managing complete turn key projects for laboratories requiring modular and fixed casework. Established in 2003, CGMP has experience in various aspects of laboratory and process planning, design, equipment design/procurement, FAT, installation, SAT, and CQV. The company has supported discovery and development, and is licensed for manufacturing in all laboratory aspects, including QC support, in-process, EM, and certified control. Specific responsibilities have included project scope development, planning, modeling, capital budget planning, and all aspects of complete science and technology facility delivery. We have extensive experience with various challenging room environments such as ISO 7, 5, 3, BSL 2, 2+, 3, 3+, and high potency isolator containment. Our principals have a combined 100+ years of experience and can perform planning, consulting, program management of complete installations, retrofits, and facility upgrades for our clients. CGMP is ready to satisfy any assignments made with government organizations, commercial clients, or private companies.
- Vision Development (Micro/Macro visioning)
- Situational Analysis (Modeling & Simulation of Business Plans, Enhanced Technology)
- Feasibility Studies & Cost Modeling
- Development of Master Program Scheduling
- Due Diligence Reviews & Existing Asset Analysis
- Proprietary Technology Development & Critical Equipment Systems Planning
- Laboratory Planning
- Laboratory Casework Design & Fabrication (Modular & Fixed)
- Fume Hoods & Bio-Safety Cabinets (Design, Procurement, Installation, and Start-Up)
- Critical Clean Room Manufacturing & Environmental Control / Containment Planning
- Technology Development Planning (Pilot Plant Assessment, Scale Up and Commercialization)
- Planning of Design, Construction Supervision, Commissioning, Qualifications, & Validation
- CAP X & OP X Development of Site Specific Planning (Code, Regulations, Labor, etc.)
- Regulatory Compliance Planning US FDA (CDER, CBER Quality Assurance / Quality Control & Improvement Cycles (QbD)
- Supply Chain Control Planning, Including Materials Receiving, Quarantine & Release Strategies
- Haz. Mat. Planning (Hazardous Materials Assessment, Hazardous Analysis / Hazardous Operations, Waste Characterization, Segregation & Mitigation Analysis)
- Planning of Maintenance Management Systems (Preventative & Response) & Training Certification Programs, Develop Staffing & Provide Administrative Services
- Planning of Technical Startup Assistance & Pre-Operational Checks (Life & Safety Evaluations, Safety Assurance, Risk Planning & Mitigation)
Minority owned 8(a) small business (certification in progress).
Established in 2003, our principals have over 100 years of combined experience in various aspects of laboratory planning, design, and installation.
CGMP has extensive knowledge and experience of the delivery of research and development centers (laboratories) that require complex and qualified environments, hazardous materials control, bio hazardous materials containment and segregation, clean room technology and or full FDA qualification and validation. We provide full laboratory equipment design, specification, procurement, installation, and calibration.
We have extensive experience with various challenging room environments such as ISO 7, 5, 3, BSL 2, 2+, 3, 3+, and high potency isolator containment.
We are licensed for manufacturing in all laboratory aspects, including QC support, in-process, EM, and certified control.
WESINCO – Phase 3 Realty, San Diego, Ca. 2015 - Present
Providing, engineering & procurement services; specifications development, supply chain management; vendor component procurement, product assembly, QA, product shipping and installation oversight. Clients include Achaogen, Clara Foods, Poseida, Escape, Tizona, Harpoon Scientific, BioLife Systems, Applied Molecular Transport & Explora Life Sciences
University of South Florida, Tampa, FL. – 2015
A 175,000 SF natural sciences and chemistry research building. This project included a new 102,000 SF laboratory tower and complete renovation of the existing teaching and research laboratories.
US Pharmacopeia, Rockville, MD. – 2006
A 125,000 SF facility designed to accommodate a complete testing and analytical laboratory for use in the standards evaluation process conducted by USP.
Upjohn, Kalamazoo, MA. – 2004
A global study to develop a relocation and consolidation plan for the pilot plant and scale up facilities in St. Louis. The study included asset utilization analysis, relocation strategies, location plans and cost projections for the multiple phases of the plan.
The University of Wisconsin, Madison, WI. – 2003
Providing design consultation for a cGMP compliant, biologics manufacturing facility to produce purified, clinical trial products, in bulk (API) forms. Perform final formulation, filling, labeling and storage/release of final dosage forms for clinical application. The facility is designed for sustainable Phase I, II clinical trial materials production only.
