617-274-0642
info@RegulatoryClinical.com
“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
You need a regulatory strategy that supports business objectives, reduces regulatory risk, and accelerates regulatory approvals of high value claims…
You need to support your product development strategy with clinical data to evaluate its safety and efficacy….
You need efficient, economical and compliant cGMP / Quality System to support your product approvals and offerings….
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
