Making Great Ideas Thrive

CharlesGroup helps world leaders in the pharmaceutical and medical device space with product definition, development and validation.

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CharlesGroup is a highly select team
of research and product development experts
founder

Charles Albert, founder

Medical device is our wheelhouse.
With over 25 years experience developing medical device and drug delivery technologies, we understand what often goes wrong in development,
and help you avoid the breakdowns
CharlesGroup services and regulatory compliance
search Research
Qualitative Services

Ethnographic studies, IDI’s and focus groups, Large scale non-IRB studies supporting developments.

Quantitative Services

Formative and summative studies including IRB Controlled studies where CGI serves as Principal Investigator. We’ve conducted regional, national, and international studies.

HFE (Human Factors Evaluations)

Consistent with HE75 and the FDA/CDRH Feb 2016 guidance

design Design
Design

Early conceptualization, 3D Modeling
Model and prototype development, support/procurement
User Experience design
Concurrent Field Research supporting rapid iterative cycles
Package design, development and validation

Engineering

Systems analysis
Product and mechanism design
Materials analysis, assembly design, part design
Analytics including FMEA

doc Regulatory Compliance
Quality system

Our FDA and ISO compliant quality system helps assure the integrity of our staff, processes and results.

Document Control

Our document control system is compliant with US and International regulatory guidelines.

The need

Your customers must use your device effectively to receive the benefits of your technology.
We look at the complete product system and vet every point of contact your customers have.
We assure all the parts work in concert to produce the desired therapeutic result.
We design the errors out of your product.

Charles Group Advantage

Our methods of integrating customer research with product design help assure you develop an optimal product. Your clinical trials will run smoother, you’ll have a better shot at on-time launch.

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Phase 1

Research

dev

Research into market practices and competitors to speed PRD generation.

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Phase 2

Design - Build - Test Cycles

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Fast design, build, test iterations, evaluated with customers helps development design errors out, and makes clear what what your customers care about, and what they don’t.

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Phase 3

Smooth clinic trial

  • + Packaging + Instruction
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Well developed products* test better in the clinic.

Fewer trial errors means better data, and a better chance of on-time product launch.


*Including clinical kit and instructions.

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Phase 4

On-time launch

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On-time launch

builds market confidence.

Market confidence = Market Share.

Testimonials
Aerogen

Copy to be generated and approved

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Roche

“CharlesGroup showed much professionalism and innovation in their approach to research. From the design of analytical tools used to the presentation of findings, they are a class act.

Their recommendations on process improvement and our business opportunities did not fall on deaf ears.

We are enjoying our working relationship with CharlesGroup”

Raymond Rivers
Manager Marketing
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Nektar

“Excellent research, producing insights into our customers and their assessments of our technology, helping inform both our marketing and development efforts.

CharlesGroup helped us make critical decisions, and kept our process moving quickly giving us confidence in the decisions we make.

Mona Chada
Director of Marketing
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Novartis

“We have trusted CharlesGroup numerous times to design and field large Human Factors studies in accordance with our strict clinical guidelines, which require IRB review and on-site medical oversight.
In todays world, it is rare to find a partner that is personally accountable and truly engaged. CharlesGroup is that rare partner. Their conscientiousness, resourcefulness, responsiveness and creativity make them an invaluable asset to our development teams”

David Maltz
Director Device Technology
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Gilead

“At a challenging time for our company, CharlesGroups process help unite our team, clarify what we needed to do and helped us make the best decisions. We got a great solution fast”

Ruth Bailey
Director of Marketing
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Hewlett Packard

“CharlesGroup’s method of blending product design and research is a winning combination”

Doug Sexton
Product Manager Drug Delivery Solutions
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