Phoenix Regulatory Associates Ltd.

placeholder+image
About US:

Phoenix assists with regulatory planning, premarket applications, general compliance, CGP, IRB compliance, GLP, PAI audits and its preparation, validation, implementing GMP/ISO 9000, and solving regulatory problems, such as 483s, warning letters and import matters. Phoenix' seasoned consultants consists of former FDA staff and industry experts who keep in touch with changes in policy, regulations and personnel at FDA. Phoenix -- located in the Washington, DC area-- combines decades of experience with a commitment to giving each client maximum value. Phoenix helps its clients solve problems throughout the product's regulatory lifecycle. We look forward to providing you with high-quality service.

Web Site: www.phoenixrising.com
Address:

21525 Ridgetop Circle #240
Sterling, Virginia 20166
United States
Phone: 703.406.0906
Fax: 703.406.9513
Email: phoenix@phoenixrising.com

Contact:

Dr. C.K. Gund
President

Dr. Clyde Takeguchi
Executive Vice President

Geographic Areas: China
Japan
South Korea
Australia
New Zealand
Europe
South America
North America
Canada
United States
India
Business Type: Consulting Services
Products: Biologics
Blood 
Combination Product
Cosmetics
Medical Devices
Class I
Class II
Class III
Drugs 
Patent Drug/New Drug/Brand Name Drugs
Generic Drugs
Orphan Drugs
Over-the-Counter (OTC)
Veterinary Medicines
Food
Professional Responsibility (Production): Submission/Registrations
Professional Responsibility (Regulatory Process): Good Laboratory Practice (GLP)
Quality System (QS)
Postmarket Surveillance
Good Clinical Practice (GCP)
Good Manufacturing Practice (GMP)
Investigational New Drug (IND)
Investigational Device Exemption (IDE)
New Drug Approval (NDA)
Premarket Approval (PMA)
Premarket Notification (510k)
Registration Establishment
Other Professional Responsibility: Strategic Planning
Training/Education