”You’ve made a significant difference to our QA organization”
Head of QA for major US Pharmaceutical Company.
...............................
“Smart Consulting Group has made a major contribution to our manufacturing strategy and how we plan to operate our plant in the future”
General Manager for major US Pharmaceutical Company.
At Smart Consulting we are pharmaceutical consultants that provide you with the competitive edge you need to be the market leader in healthcare products. We can offer you the health care consulting your company needs.
Whilst we offer a range of services, some core areas
include:
Lean Manufacturing
FDA Regulatory Services
Quality/Quality Compliance Services
FTC Specialists
We offer advice on vaccine policy, product development experience, process development and manufacturing expertise, lean efficiency production strategies, business Process Optimization, and statistical support in vaccine development.
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Lean manufacturing
A key mission objective is to enable our clients to grow and compete globally. No where else at this moment in time is there a greater opportunity than through the application of Lean & Lean Manufacturing within the Life Sciences Sector.
Through the implementation of waste reduction & process improvement strategies we add value to our client businesses and provide them with the competitive edge.
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Quality and Compliance Services
We offer Quality & Quality Compliance Services designed to meet your
needs. Whether you require audits of your suppliers, assessment of your
quality systems or a resource to fill a void, we can provide the expert
resource necessary to meet your objectives.
Some of our many services include Quality Audits, Quality System
Strategy, Design & Execution and Quality Assurance support in
Investigations, Change Control, Documentation and Product Release.
Due to the depth of experience and resources available using the Smart
team, clients easily make their project objectives on-time and on-budget.
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Drug / Device Combination Products help
Our consulting team has been handling these issues for over ten years with some of the leading companies and has sponsored sessions at key industry conferences discussing Combination Products.
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We use experienced resources to deliver your requirements on-time and on-budget. We will prepare your drug and device submissions,(IND,NDA,ANDA,BLA,510K,IDE,PMA), conduct content reviews and risk assessments. We provide third party verification services to meet obligations and commitments to regulatory authorities.
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Specialist Regulatory Consulting with Federal Trade Commission (FTC).
This is a specialized area within the regulatory compliance sector of
the company's business. Denise Smart Esq., Managing Partner with Smart
Consulting Group, LLC has developed this specialty area working with the
FTC (Federal Trade Commission) as an interim monitor to oversee the
divestiture and transfer of assets in situations where the FTC has
identified a potential anti-competitive impact of a proposed merger or
acquisition.
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• Why Choose Us?
Flexibility
Our project associates are flexible. We can take lead and manage project resources, work as substitute staff and work as temporary team members.
Experience
Proven results with track record. Critical mass of resources enables us to provide complete turn key solutions. Commitment to development of multiple solutions to difficult problems. No one solution approach to health care consulting. Ability to work under pressure in high profile, visible project situations and meet timeline objectives.
Excellent Execution
Production of excellent work product through continued refinement and internal peer review process. Cost conscious and time line driven to provide results which keep the project focused. Hands-on technical execution by experienced staff that understands strategic implications of work product and health care consulting.
• Case Study: Lean efficiency analysis of QC function for a major pharmaceutical manufacturer
• Case Study: Lean Laboratory Process for Medical Device Company
• Case Study: Divestiture of a Prescription Generic Pharmaceutical Pursuant to an Federal Trade Commission Consent Order
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