21 CFR Part 210 and 211 Consulting Services
Maintaining compliance to 21 CFR Part 210 and 211 is critical to the pharmaceutical industry. Life Science companies that require assistance in establishing, maintaining, or improving their quality systems and procedures because of compliance violations can leverage RCA’s global compliance consulting network for remediation support.
We can assist with enforcement actions by developing long-term strategies that will help your organization maintain compliance through continuous process and system improvements. Impact analysis and risk assessment activities can include but are not limited to:
- Developing strategies and define tactical actions for GMP areas to regain compliance with US FDA and other regulatory bodies.
- Development of Training Modules for comprehension to various parts of the regulations
- Data integrity assessment
- In-depth 6 System Audits & recommendations for improvements
- Supplier Quality programs & Quality Agreements
- Auditing services to verify any non-compliance gaps across manufacturing operations and supporting quality functions
- Quality Systems: Quality Control, Quality Assurance, Document Control, Complaint Handling, Investigations & CAPA’s, Batch Record Review & Release
Our other pharmaceutical remediation services include:
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
