Experts in Life Science Product Regulation and Manufacturing

SMART CONSULTING GROUP is an expert life science consulting and staffing support firm that provides scientific, technical, quality and regulatory assistance to the life science industry. SCG provides unique insight, analysis and solutions to the complex world of medical product development and licensure.

OUR HOME TEAM

FOUNDER, DENISE SMART, ESQ.

With over 30 years of experience in the Pharmaceutical and Biotechnology industry overseeing Process Development, Manufacturing and Quality issues, Denise has become known as a problem-solver of complex biopharmaceutical industry issues. She, along with her team of SMEs, have helped companies and government agencies navigate the complex challenges of compliance, safety and GMP.

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

Skip Ivison

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.

Mary Fisher

Director, Marketing and
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.

Kristin Carrier

Operations and Accounting

Kristin handles all the nuts and bolts of our operations. From bookkeeping to keeping SCG’s procedures working smoothly and efficiently, she is an invaluable team member and liaison for our clients and staff.

OUR AWAY TEAM

We have an outstanding group of Subject Matter Experts who are ready to make your team complete. Here’s just a few of our experienced SMEs:

  • 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)
  • Biostatistician
  • Medical statistical programmer
  • Product safety/pharmacovigilance

PAST PERFORMANCE

  • 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

Quality Surveillance

  • 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.”

Owner and President

Midlantic Microbiology Consulting

contact

610.344.9217
inquiries@smartconsultinggroup.com

PO Box 884
West Chester, PA  19382

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