About Smart Consulting Group
On July 26, 2014 Conceptual
MindWorks, Inc. (CMI), along with team members Smart Consulting Group, LLC and
Tunnell Government Services in connection with Federal Trademark Office, began
providing scientific and professional staffing support to the Biomedical
Advanced Research and Development Authority (BARDA). Team CMI’s
highly-specialized and experienced pharmaceutical subject matter experts and
senior project managers play a critical integral role in BARDA’s successful
analysis, development and manufacturing of medical countermeasures that address
the public health medical consequences of chemical, biological, radiological,
and nuclear (CBRN) events, pandemic influenza, and emerging infectious
diseases. The on-site TeamCMI workforce
provides an at the ready experienced group of broad-breadth technical
professionals of varying titles to help plan and monitor third party drug,
vaccine and diagnostic device testing in animals and humans. Our embedded team
has established foundations both nationally and internationally, providing
widespread opportunities and outstretched connections as we continue to expand.
Smart Consulting Group is a progressive consulting company that is providing technical, quality compliance and regulatory assistance to the healthcare industry with specific focus on:
- Medical Devices
Using a combination of seasoned industry professionals and former FDA professionals, the company has developed the capability to provide efficient, cost effective compliance solutions (affordable innovation) to current industry problems, on budget, on time and Right-First-Time.
Our company’s mission is to provide outstanding technical and regulatory compliance assistance to enable our clients to meet their product objectives. In fulfilling this mission, we act as a bridge from our clients problems to great solutions, developed in partnership.
The demands of the modern healthcare product industry are such that a one-size-fits-all approach is no longer relevant and this is giving way to a more tailored bespoke approach where boutique style and quality approaches are required to produce the right solutions with the appropriate quality.
It’s important that quality is built in to assure performance and confidence and processes need to be streamlined to produce a portfolio of solutions to meet the variable needs of the client.
At Smart Consulting Group, we optimize user experience through our think-tank approach, which focuses on making an intuitive system rather than a mechanical system.
In fulfilling this role, we provide services in a number of broad categories including, but not limited to:
- Quality Compliance
- Regulatory Affairs
- Product/Process Development/Manufacturing
- Laboratory Services
- Project Management
- Interim Monitor for Federal Trade Commission
- Clinical Monitoring and Health Economics Evaluation
- Consent Decree Consulting for FDA
We have expertise in solid dosage forms, parenteral pharmaceuticals, a wide range of biological products, vaccines, recombinant products, monoclonal antibodies, cell therapies, tissue engineered products and device-combo products.
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