Smart Consulting Group is certified as a Women’s Business Enterprise (WBE) through the Women’s Business Enterprise National Council (WBENC), the nation’s largest third-party certifier of businesses owned and operated by women in the US.
We are also certified as a Women-Owned Small Business by SAM.gov.
We recognize the commitment to supplier diversity that is embraced by corporations and government agencies today, and we can add diversity to your supply chain.
Smart Consulting Group provides expert technical and regulatory support for biotechnology, medical devices, pharmaceuticals, vaccines, and specialty products, solving complex challenges for both the industry and governments.
Serving the life science industry since 1999, we offer unique insight, analysis, and solutions to the complex world of medical product development and licensure.
Our expertise includes 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.
OUR HOME TEAM
FOUNDER, DENISE SMART, ESQ.
Denise’s experience and capabilities include:
- Attorney licensed in Delaware (2000)
- Interim Monitor for Federal Trade Commission
- Project Leader for Consent Decree Strategic Consulting Services to FDA Office of Manufacturing Quality
- Implement core Quality System Elements, including Change Management, Documentation and Training
- Establish Regulatory Inspection Management processes. Deliver inspection readiness training
- Project leader for Regulatory Strategy Advisory services
- Inform clients of Life Science Industry regulatory and legal developments
Vice President, SME Acquisition and Management
Skip has been in the Life Science industry for over 30 years. As a Laboratory Manager for DuPont Merck Pharmaceuticals, he gained invaluable knowledge of the importance of a strong team. Most recently, as the Director of Human Resources at Endo Pharmaceuticals he was successful in integrating people with process to build a professional team of influencers in the pharma industry.
Director, Creative Communications
Mary has over 30 years of corporate marketing communications experience working in the pharma industry, both as a hands-on designer and creative director. From product launches to industry conferences, she has worked with many industry leading companies through her career: SmithKline Beecham, Pfizer, Zoetis, West, Mallinckrodt, and Aetna International.
Lori brings over 30 years of marketing experience working in the pharma, biotech, and clinical research industries. In her role at Smart Consulting Group, Lori leads the marketing and messaging strategy, planning, and execution and serves as liaison with the creative team, Subject Matter Experts, and Business Development teams.
OUR AWAY TEAM
We have an outstanding group of Subject Matter Experts who are ready to make your team complete. Our SMEs specialize in:
- Analytical development
- Solutions architecture / value engineering / requirements engineering
- Software development SME for In Vitro Diagnostics (IVD) and medical devices
- Quality systems and design control SME for IVD and medical devices
- Statistical analyst and modeling SME in clinical validation for IVD and devices
- Radiation medical counter measure (MCM) development
- Pharmacologist with ADME (absorption, distribution, metabolism, excretion) experience
- Burn/wound healing
- Biologics formulations development
- Clinical Operations/development
- Clinician with relevant specialty (e.g., Key Opinion Leader)
- Medical statistical programmer
- Product safety/pharmacovigilance
- Provide complex Subject Matter Expert staffing support to BARDA
- GS10F0273V Schedule 874-1: Development of Strategies in Handling High Profile Consent Decrees
- HHSF223201620432G: Consent Decree Management Services for CDER Office of Compliance
- HHSF223201210242C: Development of a Strategy, Goals, Recommendations and Providing Assistance in managing FDA’s Implementation of a Consent Decree, with a Focus on Application Integrity Policy (AIP)
- HHSF223201510572G: Consent Decree Management Services for CDER (Task Order under GS10F0273V)
- Montana State University MilTech Contract #K17-010B Task order name: FDA EVAC Catheter Support: Provide Subject Matter Expert support including regulatory and product development strategy for a cardiovascular device
- Subcontractor to Engility on a multiple award IDIQ for medical product research and development. Contract reference: W81XWH-15-D-0042
INDUSTRY PAST PERFORMANCE
- SCG’s management and consulting team members have served as third party auditors on FDA Consent Decrees dating back to the inception of the company in 1999. Our experience includes performance of verification audits to confirm satisfactory execution of Consent Decree Work Plans and obligations, performance of third party batch certification audits and performance of Application Integrity Audits to assess the validity of data used to support NDA / ANDA applications and that changes and reporting obligations were performed as required by regulations.
- Evaluating pharmaceutical manufacturing and testing firms is one of SCG’s core capabilities. SCG consultants routinely perform assessments and audits of company operations including but not limited to: General GMP, GLP and GCP audits, audits for sponsor companies of suppliers and contract manufacturers and testing facilities, regulatory and technical due diligence assessments, lean analysis, Pre-approval assessments, data integrity and data management audits. Warning Letter and Consent Decree audits performed include: Centeon, Wyeth, Schering Plough, Elan, Watson, Ben Venue and Johnson and Johnson. Supplier audits performed include raw material and API suppliers, contract manufacturing and packaging facilities and testing labs (clinical and commercial), distribution and warehousing.
- Audits include the preparation and approval of an Audit Plan, scheduling and advance information requests, travel coordination including obtaining visas where required, performance of the audit, identification of issues and reporting and closure of the audit. All work is performed in accordance with audit schedules and reporting timelines.
- SCG as an organization and individually through its consultants has extensive experience providing quality surveillance support in the assessment, site qualification, due diligence, remediation planning, coordination, scientific and regulatory assistance, execution, verification and certification of compliance.
“Denise has a solid grasp of GMPs and an inherent ability to tease the truth out of complex issues.”