”You’ve made a significant difference to our QA organization”
Head of QA for major US Pharmaceutical Company.
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“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
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.
FDA Regulatory Services
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.
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.
FTC Specialists
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.
• 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
