Regulatory Compliance Associates knows how quality compliance crises can significantly impact your business—and we have the experience to manage those crises. Our areas of expertise include identifying and assessing any deficiencies to help determine the best approach and compliance assessment solutions. We can perform a “deep dive” into any quality system or process that you feel needs a good top-to-bottom assessment or audit.
- Audits
- GMP 6 System Audits
- Supplier
- Current Good Manufacturing Practice (cGMP) Compliance Audits
- Current Good Laboratory Practices (cGLP) Compliance Audits
- Data Integrity
- Quality System Compliance Audit
- Internal Audits
- Contract Manufacturer Audits
- Supplier Audits
- Assessments
- Current Good Manufacturing Practice (cGMP)
- GMP Gap Assessments
- GMP 6 System Assessments
- International Organization for Standardization (ISO)
- Quality Infrastructure
- Corrective and preventive Action (CAPA)
- Mock Pre-Approval Inspection (PAI)
- Data Integrity
- Mock FDA Inspection
- 503A and 503B
Additional services related to assessments include:
- 21 CFR Part 11 / Annex 11 Assessment
- 21 CFR Part 210 and 211 Assessment
- Good Laboratory Practice (GLP)
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].
