Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance assurance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.
Our Compliance Assurance services for the Pharmaceutical industry include:
- Assessments – cGMP, Quality Infrastructure, PAI, Validation, Facilities and Maintenance, Laboratory (GLP), Process Assessments to Streamline and Optimize New and Existing Systems.
- Audits – Supplier, API, Contact Manufactures (CMO), Internal, Quality Systems, Baseline, Verification, Clinical (CRO) and Clinical Manufacturing), Data Integrity, 503A & 503B, Combination Products.
- Regulatory Agency Response – FDA, 483, Warning Letter, Consent Decree.
- Preparation, Training, and Inspection Readiness – Mock Inspections, Back Room/ Front Room set-up and process, Inspection Assistance, Response Letter Assistance, Proof Book Development.