Smart Services

Pharmaceutical & Life Sciences Services

Smart Provides Core Pharmaceutical Services & Dozens Of Support Services To Ensure Your Company’s Competitive Success In Today’s Market.

Smart 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 instead of on unnecessary paperwork and red tape. 

Our 70+ combined years of “Inside Pharma” experience, combined with inside-FDA experience, gives you the greatest combination to have the competitive edge in today’s increasingly challenging economic environment.

To implement 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-the-lab and on-the-line hands-on experience in every core area of your business. Here are just a few of the dozens of ways we functionally help our clients actually apply the systems and training we provide.

 

 

Specialty Services

 

Smart Consulting Group also offers Specialty Services. Click below to learn more:

 

 

 

 

Other Smart Services

Quality Services

  • Temporary QA Management Support
  • Compliance Assessments; GMP,GLP,GCP,GXP
  • Mock FDA and EU Audits
  • Internal & External Quality Audits
  • PAI (pre-approval inspection) Audits
  • Third Party Audits of Contractors, Suppliers, Raw Material/Intermediate sources
  • Annual Product Review
  • Quality Agreements
  • Learn more about Quality Services…

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

  • Development of Training Programs
  • Mapping Training Quality System Elements
  • Development of Training Documentation
  • Specialist Training Courses; eg Practical QC Management,GMP Training
  • Group Training Sessions
  • Shadow Coaching
  • Learn more about Training…

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…

Laboratory Services

Regulatory Services

  • Domestic & International Expertise
  • Regulatory submissions, preparation, review, application audits
  • IND.NDA,ANDA,BLA,510K Submissions
  • Regulatory Strategy; Pharmaceuticals, Biologics, Medical Devices; Combination Products
  • CMC Support
  • 505(2B) Strategies
  • Regulatory Due Diligence Services
  • REMS (Risk Evaluation Mitigation) Strategies
  • 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…

Process & Manufacturing Services

  • Process Development Support
  • Fermentation/Cell Culture Consulting
  • Clinical Trials Manufacturing Support
  • Manufacturing Strategy
  • Lean Manufacturing Strategy
  • Technology Transfer Consulting; Strategy, Policy Procedures
  • Manufacturing Operations Troubleshooting; Sterile, Non-sterile
  • Learn more about Process & Manufacturing Services…

Medical Devices

Facilities Services

Specialist R&D Services

Clinical Trial Management