Compliance & Validation Services
G&M Health provides specialized compliance, validation, and auditing services for the pharmaceutical, biotech, and life sciences industries. Our expertise ensures that your business meets all regulatory requirements while streamlining operations.
Auditing & Monitoring
We provide comprehensive audits and monitoring programs to assess compliance risks, improve operations, and prepare for regulatory inspections.
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Vendor Audits – Ensure compliance across third-party partnerships.
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Speaker Audits – Evaluate HCP speaker programs for regulatory adherence.
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Internal Assessments – Identify and mitigate internal compliance risks.
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Operational Assessment – Optimize processes to align with industry standards.
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Monitoring Programs – Ongoing compliance tracking for continuous improvement.
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HIPAA Risk Assessment – Protect patient data and ensure regulatory compliance.
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FDA / DEA Mock Audits – Prepare for regulatory inspections with expert-led audits.
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Field Ride Along Audits – Assess how your sales representatives engage with healthcare professionals
System Validation
Our validation services ensure your software, equipment, and processes meet industry standards, reducing risks and ensuring compliance.
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Software Validation – Confirm functionality and compliance of regulated software.
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Equipment Validation – Ensure that all equipment operates according to compliance standards.
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Cold Chain Qualification – Validate temperature-controlled supply chains.
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21 CFR Part 11 Analysis – Ensure FDA compliance for electronic records and signatures.
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HIPAA Security – Implement robust security measures for healthcare data.
Compliance Support
Our compliance services guarantee adherence to state and federal regulations, leveraging streamlined processes and our extensive industry expertise.
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Compliance Program Support – Compliance lead support and customized commercial compliance advisory support to guide your organization through regulatory requirements, risk management, and industry best practices to ensure full compliance.
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Policies and SOPs – Develop Compliance related policies and SOPs that are tailored to your commercial strategies.
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Training – Equip your workforce with the essential knowledge to carry out their duties in full compliance.
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MLR – Engage Medical Reviewers, Regulatory Reviewers and Coordinator Roles on an ad - hoc or ongoing basis.
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Hospital Credentialing – Ensure that your sales representatives are properly licensed to perform their roles in compliance with state regulations.
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Jurisdiction Support – Ensure that your sales representatives are properly licensed to perform their roles in compliance with state regulations.
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State Entity Licensing – Ensure the proper licensing of your facilities to correspond with your operational needs.
We’re Here to Help!
Have questions or need assistance? Get in touch with our team for expert guidance and support.
Somerset, NJ 08873, United States
1980 N Atlantic Ave., Suite 228 |
Cocoa Beach, FL 32931
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