Concept Design
cGMA is expert at guiding the project team through the development of programming, and producing highly operable, efficient manufacturing environments fully in compliance with regulatory expectations and internal Quality Standards. [READ MORE]
Master Planning
​A flexible and functional Master Plan offers sufficient understanding to a manufacturing site or organization to react to tactical planning decisions as they arise with a full spectrum understanding of flexibility required for the future, and to attain long term corporate goals. All too often these decisions are made incrementally, and in isolated fashion leading to disorganized facilities, and limitations on future planning flexibility. [READ MORE]
Site Search/Selection
Site search and selection requires a broad set of expertise from disparate fields. cGMA brings together a team comprised of nationally recognized subject matter experts (SME’s) who, working together with client’s operations and strategic leaders can concisely and accurately identify and evaluate the most advantageous sites. [READ MORE]
cGMP Regulatory Review
cGMA provides review and commentary on cGMP regulatory approaches and expectations for capital facility designs provided by others. In addition, cGMA produces primary regulatory review documents related to the manufacturing facility and environment, and is able to assist in FDA Type C meetings for capital projects in planning stages. [READ MORE]
Client Project Team Member
cGMA can be the expert on your team. As a member of an operating company’s technical capital project team cGMA can overview, assess and guide services provided by consultant facility engineering and design teams bringing assurance and fidelity to corporate goals for significant capital projects. [READ MORE]
Idea 2.0
IDEA2.0 has developed a rigorous and detailed design review service for new and retrofit capital projects in the biopharmaceutical and other FDA regulated industries. [READ MORE]