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Pharmaceutical & Life Sciences Services

Smart Pharmaceutical Consulting’s core services are focused on helping you create a Lean Pharmaceutical laboratory and manufacturing environment, with systems and training to maximize your production and enhance your bottom line profits.  Just as important, we help you create these programs while also helping you streamline your compliance and regulatory requirements, using automated systems that let your people focus more of their time on your core business.

Implementing these services requires a wide variety of industry-specific expertise and a knowledge base that is more than “big picture” concepts. Our team has in-lab and on-the-line hands-on experience in every core area of business. We optimize user experience through our think tank approach which focuses on making a system intuitive rather than mechanical. In fulfilling this role, we provide services  in a number of broad categories (also available as e-brochures)

Quality Services

Quality is a very broad category and a more complete list is covered in our e-brochure. To summarize, the list includes:

  • Development of a Quality Strategy
  • Building comprehensive Quality Systems together with implementation of integrated Quality System Elements
  • Experience with global concerns and implementation
  • Compliance with ‘GMPs for the 21st Century’ and ICH Q8-Q10 directives and EU legislation

We have particular skills in Change Management, Investigations, CAPA, OOS, document systems, audits, risk management and GMP information system support such as Documentum and Trackwise®.

We have special capabilities in Compliance Remediation Programs for 483’s, Warning Letter and Consent Decrees/Application Integrity Policy. Learn more about Quality Services

Quality System Development

  • Design of individual Quality Systems
  • Mapping of existing systems and transition assistance to new Best Practice Models
  • Customization of Quality Systems for required Quality System Element; QSE
  • Change Control/Management Development, De-bugging, Analysis
  • Deviations/Investigations/CAPA Systems
  • Contractor Management Systems
  • Quality Policy, Quality Charter, Quality Counsel
  • Assistance with selection of database /system to support QS eg Trackwise, Isotrain
  • Adverse Event Reporting System; Design & Audit
  • Learn more about Quality System Development

Project Management

Through project management, we provide an integrated approach to solution building.Services include:

  • Process mapping
  • Best practice strategy
  • Definition of goals
  • Work breakdown structure
  • Responsibilities matrix
  • Project Gantt Chart
  • Program Management and Oversight (Customer Driven Program Management, CDPM)
  • Statistical analysis support for trials and regulatory issues

Document Systems

  • Design of Systems and Management
  • Document Design & Preparation
  • Manufacturing Batch Records
  • Standard Operating Procedures
  • Policy Documents
  • Quality Agreements
  • Master Plans
  • Validation Documents
  • Specialist Reports
  • Learn more about Document Systems

Training

Through Smart Academy, we use our clients to transform their ideas into winning products.Custom courses are available for a variety of topics as well as individual mentoring type coaching (Shadow Coaching), which provides experienced one-on-one total immersion training/guidance for maximum results. A brief summary of training courses include:

  • General GMP
  • QC Laboratory Manufacturing
  • Root Cause Analysis
  • Investigations
  • Statistical Analysis
  • CAPA
  • Validation
  • CMC
  • EU Clinical Directives
  • Clinical Monitoring

A more complete listing is provided in our Training brochure. Learn more about Training

Laboratory Services

We focus on a Lean approach to laboratory operations and services. Services include:

  • QC Strategy
  • Assessments/QC flow
  • Lean  Laboratory design, flow and operation
  • Value Stream Improvement
  • Sample Management
  • Data Management Systems
  • Mentoring

Our approach with laboratory services is always to produce a balanced strategy which pays attention to compliance efficiency and effectiveness.

If any one of these is out of balance, the laboratory will not run smoothly and collateral problems will arise which will impact overall business goals. This is why we take a holistic approach to laboratory operations and laboratory operational strategy. Go Lean and Unleash Your Laboratory’s Full Potential. Learn more about Laboratory Services

Regulatory Services

Using our integrated and experienced approach we provide assistance for:

  • Pre-IND strategy
  • IND, NDA, ANDA, BLA, 510K submissions
  • CMC support and preparation
  • Supplement Submissions
  • Package inserts/labeling
  • Annual Reports
  • Pharmacovigilance and post market safety surveillance
  • EU Clinical Directive

Our team is hands-on and works closely with operational team members to ensure that the appropriate technical information is provided for maximum efficiency. Learn more about Regulatory Services

Business Services

  • Development of Business Process Management Solutions
  • Meeting Facilitation/Problem Solving & Brainstorming Sessions
  • Team building Services
  • Process Mapping Services & Solutions
  • Business Plan Preparation
  • Competitive Analysis Services
  • Interim Monitor Services for Federal Trade Commission/Anti-Trust Divestitures
  • Learn more about Business Services

Interim Monitor for Federal Trade Commission

This is a unique niche capability that we supply to the government.

We are providing complete specialized pharmaceutical divestiture expertise to monitor the transfer of technology, products, equipment, personnel and confidential business information to acquirer companies in anti-trust cases.

Process Development, Product & Manufacturing Services

“Using our partnership approach, we assist our clients to change great ideas into reality.”

Whether the products are biologics, solid dosage forms, parenteral or device-combo products, we use a rational approach to their development and manufacture. Common with our laboratory services, we focus on a Lean approach to manufacturing operations. Our focus is on good process design, where process mapping is a key component of our technical services implementation including:

  • Layout of process flows
  • Equipment
  • CMC sections for submissions
  • Development of specifications, validation, technology transfer, contamination control, and facility design review.

Working closely together, our cross-functional teams produce the best solutions on scope and within budget.

Key services include:

  • Process Strategy
  • Process Mapping/Lean analysis
  • CMC Assistance
  • Specifications Development
  • Process Development Assistance
  • Manufacturing Operations Assistance
  • Technology Transfer
  • Scale-up Strategy
  • Bioprocess Technology
  • Process Validation
  • Stability Studies Strategy
  • Learn more about Process & Manufacturing Services

Medical Devices

Facilities Services

Specialist R&D Services

Clinical Trial Monitoring/Management

Clinical Monitoring and Health Economics Evaluation

This covers all usual CRA activities including:

  • Site Training
  • Site Monitoring
  • Drug Accountability
  • Records Cleaning

As well as complete niche fit analysis of the health benefits of the product and its economic evaluations.

Statistical Analysis is also a core function of this team.

 

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As a small business, we are proud of the government services that we continue to provide to our astounding client base. At the core, the SCG team is passionate about the industry, making it a goal of ours to provide expert technical government work for our clients. Talk to us today about SCG Government consulting services.

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