Regulatory Compliance Associates Inc. is dedicated to providing value-driven compliance solutions that are sensitive to business needs. Our well tailored approach to compliance allows us to carefully evaluate each project and determine the correct level of remediation effort required, thus permitting us to maximize value for both large and small projects. The RCA team is comprised of industry experts with technical compliance expertise in the pharmaceutical industry. Our personnel are equipped to offer best practice solutions and effective, efficient implementation.
Regulatory Compliance Associates Inc. will help you achieve compliance goals in a variety of regulatory scenarios, including:
- Adverse Drug Events - Reporting and Regulatory Requirements
- Drug Master Files - Compilation and Remediation
- Product Development
- Design Control
- Risk Management
- Facility and Equipment Validation
- Process Validation
- Computer Validation
- Cleaning Validation
- Aseptic Processing
- Quality System Development and Remediation
- Management of Change
- CAPA Remediation
- Document Management
- Quality and Regulatory Training
- Good Documentation Practices
- Good Manufacturing Practices
- Good Clinical Practices
- Good Laboratory Practices
- Manufacturing Optimization
- Project Management
- Metrology and Calibration
- Technology Transfer
- Preparation for FDA Inspections
- Quality and Supplier Audits
For more information see Services