Phoenix Regulatory Associates, Ltd.

Phoenix Regulatory Associates, Ltd. FDA/Regulatory Help for the Pharmaceutical Industry. www.phoenixrising.com

21525 Ridgetop Circle, Suite 240 Sterling, VA 20166-6510 United States Website: www.phoenixrising.com Phone: 703-406-0906 Fax: 703-406-9513 Description: FDA regulatory consulting assistance in the US and globally to obtain premarket approval, stay in compliance and resolve regulatory problems.

• Information Technologies (formerly Computers and Related Equipment section)  21 CFR 11 Compliance
• Information Technologies (formerly Computers and Related Equipment section)  Computer-Assisted NDA Services
• Information Technologies (formerly Computers and Related Equipment section)  Computer-Integrated Manufacturing
• Information Technologies (formerly Computers and Related Equipment section)  Computer-Related System Validation
• Information Technologies (formerly Computers and Related Equipment section)  Quality Assurance Audits
• Information Technologies (formerly Computers and Related Equipment section)  Regulatory and Part 11 Risk Assessment
• Information Technologies (formerly Computers and Related Equipment section)  Software Validation
• Information Technologies (formerly Computers and Related Equipment section)  SOP Development
• Information Technologies (formerly Computers and Related Equipment section)  Statistical Analysis
• Outsource Services (formerly Contract Testing and Services)  Auditing
• Outsource Services (formerly Contract Testing and Services)  Drug Master File Establishment and Maintenance
• Outsource Services (formerly Contract Testing and Services)  Excipient GMP Auditing
• Outsource Services (formerly Contract Testing and Services)  Expert Testimony
• Outsource Services (formerly Contract Testing and Services)  IND/NDA Submission Support Services
• Outsource Services (formerly Contract Testing and Services)  Process Validation Studies
• Outsource Services (formerly Contract Testing and Services)  Quality Assurance, Quality Control
• Outsource Services (formerly Contract Testing and Services)  Regulatory Affairs Consultants
• Outsource Services (formerly Contract Testing and Services)  Training, CGMP/HPB/FDA Compliance
• Outsource Services (formerly Contract Testing and Services)  Training, Process Validation
• Outsource Services (formerly Contract Testing and Services)  Validation Services