Compliance Consulting

Compliance Consulting

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image-goes-here G&M Health is equipped to Connect your Compliance Dots. With extensive expertise and experience in pharmaceutical compliance, G&M offers a wide range of compliance consulting services to the pharmaceutical industry.

Compliance Department / Officer Support
G&M offers you the flexibility to structure the support you need by offering several service models. From minimal coverage to support your existing Compliance Department to an outsourced Compliance Department model, G&M will work with you to ensure you get the help you need.

HIPAA Risk Assessment
Due to the recent passing of amendments to HIPAA and HITECH Laws, now is the time for companies to confirm proper maintenance and safeguarding of Protected Health Information. Our privacy experts are ready to evaluate your current processes and procedures so you can be sure you are in compliance with all requirements.

CIA Risk Mitigation
Corporate Integrity Agreements have become commonplace in the pharmaceutical industry. G&M is your source for providing the oversight and guidance necessary to ensure adherence is maintained.

Auditing Services
G&M is a trusted partner in the pharmaceutical industry for conducting audits on third party vendors who perform regulated functions. Whether vendors are storing and/or shipping your product, performing sample accountability and reconciliation services or managing/maintaining your CRM system, G&M has the auditing experience you can count on.

Want to ensure you and your staff are ready for an upcoming FDA or DEA audit? Let G&M perform a Mock Audit on your organization. Our auditing team has represented companies in numerous FDA and DEA audits. After we complete our simulated experience, you can rest assured that you will be prepared for the real thing.

Standard Operating Procedures Development
G&M considers clearly defined and consistent SOPs to be a vital component for the success of a company. Having well documented SOPs aides in workforce training and establishes clear expectations of your employees. G&M works directly with your team to ensure processes and objectives are understood and will also identify any gaps and/or areas of improvement so you can be sure your bases are covered. Whether you are in need of a new set or looking to update your current SOPs, G&M is at your disposal.

Training
Proper training of personnel is critical in maintaining your Compliance Program. Learn how G&M’s expertise in a wide variety of regulated subject matters can help support your organization with a comprehensive training program.

 

Contact us at info@gmhllc.com to learn more.