RCA Pharmaceutical Supply Chain Consulting Services
The best way to maintain healthy business practices and get ready for an FDA audit is through training and preparation. Training employees and executives throughout your organization can lead to improved data storage and a better understanding of why proper storage is so essential for your business. Our services can help you maintain quality compliance within all aspects of your business, from design and manufacturing to packaging and distribution. These services include:
Assessments
The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our pharmaceutical supply chain consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunities to improve.
Our range of compliance consulting services includes:
- cGMP & Pharmaceutical Manufacturing
- Quality Infrastructure
- PAI, Validation
- Facilities and Maintenance
- Laboratory (GLP)
- Process Assessments to Streamline and Optimize New and Existing Systems.
Audits
Periodic regulatory audits are necessary to ensure the continued compliance of your organization. An internal audit from a pharmaceutical supply chain consulting 3rd party can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA-certified auditors is available to perform a range of internal audit services, including:
- Supplier
- API
- Contact Manufactures (CMO)
- Internal
- Quality Systems
- Baseline
- Verification
- Clinical (CRO) and Clinical Manufacturing
- Data Integrity
- 503A & 503B
- Combination Products
Regulatory Agency Response
Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. Regulatory Compliance Associates pharmaceutical supply chain consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:
- FDA Form 483
- Warning Letter
- Consent Decree
- Import Bans
Preparation, Training, and Inspection Readiness
Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need to comply with regulations and actively prepare. RCA® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections, and other medical consulting readiness solutions:
- Mock Inspections
- Back Room/ Front Room set-up and process
- Inspection Analysis & Report
- Response Letter Assistance
- Proof Book Development
- Business Relations (Leadership Development Training)
- Corporate Regulation Examples
- Regulatory Law
- Regulatory Board
- Legal Compliance
- Corporate Regulation Examples
- Industry Relations (Leadership Development Training)
- Types of Regulation
- Medical Regulations
- Security Regulations
- Cybersecurity Regulations
- Data Compliance Regulations
- Types of Regulation
Data Integrity
Training:
- Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
- Annual Good Manufacturing Practice (GMP)
- Investigations
- Corrective Action and Preventive Action (CAPA)
Consulting:
- Comprehensive Audits
- Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
- Assistance with Execution of the Remediation Plan
In the event of an audit, the information gathered during the manufacturing of pharmaceuticals—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.