Our advisory and support services are tailored to meet your unique needs.
Smart Consulting Group is a Small Woman-Owned Business (SWOB) serving the life sciences industry for more than 20 years. We support pharmaceutical, biotechnology, medical device, and government product development teams with support of operational quality, regulatory compliance, data integrity, and Quality System requirements.
Our core expertise is the development and implementation of solutions which support medical product manufacturing and control operations, regulatory readiness, supplier and vendor qualification and technical support. We provide expert guidance, assessments, strategy, and oversight in the following areas:
- Complex quality issues
- FDA compliance challenges
- Support and remediation for 483 observations, recalls, Warning Letters, and Consent Decrees
- FDA regulatory requirements conformance
- CMC strategy
- Data Integrity/Forensic Analysis
- Quality management systems
- Technology Readiness Assessments
- GMP, GLP and GCP audits (GxP auditing)
- Gap assessments and benchmarking
- Compliance and quality risk assessment
- Documentation management support
- FTC divestiture monitoring
- Laboratory compliance and operations analysis (Test Method Validation, Stability Programs)
- Product/Process development/Manufacturing
- Project management
- Quality systems design and implementation (FDA and ISO Standards)
- Regulatory requirements and interpretation
- Regulatory policy
- Regulatory strategy
- Staffing support for highly specialized talent
- Support services to facilitate organizational change
- Technology transfer strategy and oversight
- Training in GMP, data integrity, FDA enforcement, FDA regulatory requirements, inspection readiness, pre-approval application document review
- Design controls, design verification/validation, design transfer
- Validation activities (qualification, process/product, cleaning)
Our expertise extends to 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.
- Medical products regulated by CBER, CDER, and CDRH – from preclinical through licensure – across a range of products, including small molecules, protein therapeutics, blood products, vaccines, cell therapies, medical devices, in vitro diagnostics, and combination products throughout the supply chain.
- GMP compliance – data integrity, investigations, and CAPA, including expert witness support on compounding pharmacy regulations.
- Strategy and oversight in the development of cutting-edge products.
- FDA regulatory compliance – including complex quality and regulatory compliance challenges.
- Phase-appropriate quality management systems – in compliance with FDA GMP clinical product development requirements.
- Cell and gene therapy – product development, licensure, and compliance.
- Regulatory compliance of pharmaceutical/biotechnology facility design and layout – integration of process flows, commissioning, qualification, and validation of equipment.
- Remediation – design and implementation of quality management systems.
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
- Small Molecules
- Diagnostic Imaging Agents
- Various Dosage Forms
- Sterile and Non-sterile
- Monoclonal Antibodies
- Cell Therapies
- Blood Products
- 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
- 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.
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
- Travel coordination support
- Personnel management
- Other program support
- Continuous Process Improvement
- Leadership coaching and mentoring
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.