Knowledge.  Experience.  Performance.  Success.
Just one stop.

“Science has proven time and again that when the resources are provided, great progress in the treatment, cure, and prevention of disease can occur.”

Michael J. Fox

Our Services

We are Regulatory & Clinical Consulting Group, LLC (RCCG), an organization of senior consultants and affiliates, providing expert services gained from extensive “hands on” experience in regulatory affairs, clinical research, regulatory compliance, quality systems and outcomes research.

Our team of successful professionals is committed to helping clients advance their medical device, biologic, device/drug – biologic/device combination, in vitro diagnostic, and pharmaceutical development programs. Our areas of expertise include:

Regulatory affairs strategy, product classification, submission preparation and filing for medical device, IVD, biologic, drug, combination products with:

  • US Food and Drug Administration
  • Health Canada
  • European Medicines Agency
  • China, Food and  Drug Administration
  • Japan Pharmaceuticals and Medical Devices Agency
  • Australia, Therapeutic Goods Administration
  • South Korea, Ministry of Food and Drug Safety

Clinical trial strategy, design and interpretation

Regulatory compliance/quality

  • Quality systems development, independent review and maintenance
  • MDSAP preparation for US, Canada, Japan, Brazil and Australia

Health Economics Outcomes Research studies