Services

We are expert consultants to the pharmaceutical industry

Smart Consulting Group is an expert medical products consulting and staffing support firm that provides strategic, scientific, technical, quality and regulatory assistance to the pharma and biotech industry. SCG provides unique insight, analysis and solutions to the complex world of medical product development and licensure.

  • Subject Matter Experts in medical product research, development, post approval manufacture and oversight
  • Experienced in resolving complex manufacturing, development and regulatory challenges
  • Exceptional network
  • Exceptional results
  • Problem-solvers

Advisory Services

We help guide you through the complex and challenging stages of regulatory enforcement actions. We have a unique and experienced team who understands both sides of the quotient—commercial and government.

  • Quality – Developing a Quality Strategy and building comprehensive Quality Systems
  • Audits – Planning, conducting and reporting GxP audits
  • Regulatory Affairs – Analyze product and recommend regulatory strategy to meet client goals
  • Laboratory Services – Analyze laboratory operations and services for quality, compliance and efficiency
  • Product/Process Development/Manufacturing – Conduct product and cross functional process analysis to identify opportunities to improve inefficiencies and product and process quality
  • Product Strategy – Including analysis of alternatives, regulatory, clinical and business strategies
  • Industry Experience
    • Pharmaceuticals
  • Small Molecules
  • Antibiotics
  • APIs
  • Diagnostic Imaging Agents
  • Various Dosage Forms
  • Sterile and Non-sterile
    • Biotechnology
  • Monoclonal Antibodies
  • Receptors
  • Cell Therapies
    • Biologicals
  • Blood Products
  • Vaccines
  • Medical Devices
  • Product Development
  • Preclinical and Non-clinical
  • Clinical Monitoring, Auditing and Systems Management
    • Process Development
  • Analytical Method Development
  • Regulatory Affairs
  • Quality Assurance
  • Data Management Systems
  • Pharmacovigilance
    • Quality Management
  • Quality Compliance and Systems
  • Inspection Readiness and Coaching
    • Regulatory Strategy
    • Technology Transfer

We have expertise in solid dosage forms, parenteral pharmaceuticals, a wide range of biological products, vaccines, recombinant products, monoclonal antibodies, cell therapies, tissue engineered products and device-combo products.

SME Staffing

Provide Subject Matter Experts in technical, scientific and regulatory disciplines in the development and licensure of CBRN, Pandemic Influenza and Anti-microbial resistance Medical Countermeasures.

  • Candidate sourcing, identification and screening
  • On-boarding
  • Travel coordination support
  • Personnel management
  • Other program support
    • Continuous Process Improvement
    • Leadership coaching and mentoring

RQA Surveillance

Assurance. It’s the confidence of knowing. We make sure that all of the components of your operation work together seamlessly and exceptionally. We understand that it’s not just about compliance. It’s about creating a sound structure from the ground up so that you can provide the best product for the market.

FTC Interim Monitoring

We work hand-in-hand with the FTC to make sure that transactions between companies are fair, balanced and comply with the necessary government regulations. We are unique in that we have extensive experience in both commercial and government operations which gives us the insight to create a streamlined process for transfers.

contact

610.344.9217
inquiries@smartconsultinggroup.com

PO Box 884
West Chester, PA  19382

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