MAE Consulting Group

Capabilities Statement

COMPANY INTRODUCTION:

MAE Consulting Group specializes in global regulatory affairs, clinical affairs, project management and  compliance services to medical device, biotechnology and biomedical companies. We assist in the global   commercialization of medical and in vitro diagnostic devices, biologics, pharmaceuticals, cosmetics and  food/beverage products.

CORE COMPETENCIES:
Regulatory Affairs
• Strategic Global Regulatory Development
• 510(k), PMA, IDE, IRB submissions
• Feasibility, Pivotal Studies, Program Management
• GLP, GDP and GMP Compliance

Clinical Affairs
• Manage Class II and III Global Multi-Center Device
• Manage Phase I, II, III pharmaceutical studies
• Protocol and Study Documents Development
• Vendor, Clinical Site Contract and Budget Management

Project Management
• Project Management Professional Certified
• Manage $1.6M +multiple and global projects enterprise wide deployment, integration and validation Labware, LIMS Oracle R12, developing middleware
• Manage SDLC global projects passes, resources, budgets

PAST PERFORMANCE:
• Approvals in electrical-mechanical systems, disposables, assays in areas including but not limited to cardiovascular, neurology, gastroenterology, radiology, obstetrics/gynecology, orthopedic general and plastic surgery, hematology and immunology

• Pharmaceutical clinical studies include herpes zoster vaccine in oncology, monoclonal antibody dose escalation study, analgesic, CNS, NSAID, anticoagulant, antibiotic, NSAID-induced platelet dysfunction, rare diseases caused by protein deficiencies, enzyme replacement therapy for Fabry disease, and treatments for Hunter syndrome and Gaucher disease, gastrointestinal and surgical oncology, pre-cancerous colon tumors, spinal anesthesia pain management, intravenous pre-op and post-op anti-infective

• Project manage multiple global drug and device clinical studies – drug and device protocol development, multi-site monitoring, vendor contracts, IRB approval, agency approval, informed consent, adjudication meetings, site qualification

DIFFERENTIATORS:
Our focused, professional teams provide comprehensive regulatory and clinical expertise to navigate your project from early development thorough final approval. Team members have all of the needed experience and expertise to bring products to global markets. Our small-business agility and flexibility enables unparalleled cost-effectiveness.

COMPANY DATA
MAE Consulting Group LLC
www.maeconsultinggroup.com
119 North Road, Deerfield, NH 03037
Janetk@maeconsultinggroup.com
Tel: 603-452-7433 Fax: 877-636-1702

SMALL BUSINESS:
CAGE CODE: 76B02
DUNS: 079465752
NAICS CODES: 541990, 541611, 541690, 541711, 541712