Cegedim - Regulatory Compliance Consulting

Regulatory Compliance Consulting

Providing Life Sciences compliance management and regulatory support

There's nothing simple about overcoming the challenges of regulatory compliance in today's environment. Between the DEA and the FDA, you've got multiple regulatory provisions – including the Prescription Drug Marketing Act (PDMA) and the Controlled Substances Act (CSA) – to satisfy. To help you make sense of it all, BuzzeoPDMA, A Cegedim Company has spent the past decade helping Life Sciences companies in the area of compliance management and regulatory support. Our regulatory compliance consulting programs don't just improve your ability to meet federal agency requirements. They streamline your compliance activities, reducing your costs and your management burdens.

Regulatory Compliance Training

Customized regulatory compliance training programs that go well beyond the scope of standardized industry training and seminars.

FDA Solutions

The operational and regulatory expertise you need to implement and maintain FDA-compliant quality systems for the design, manufacturing, packaging, labeling, storage and delivery of your products and samples.

Cold Chain Consulting

Operational services and regulatory expertise to help you comply with US Pharmacopeia (USP) and Parenteral Drug Association (PDA) standards and FDA expectations.

DEA Solutions

The operational and regulatory expertise you need to adhere to the regulatory requirements of the Controlled Substances Act and the policies of the DEA.

Detection of Counterfeit Drugs

A streamlined, cost-effective process to independently acquire your finished drug products for usage in analytical testing and analysis initiatives as a part of your overall anti-counterfeiting program.

Suspicious Order Monitoring

A complete SOM solution that will help you better evaluate orders in accordance with DEA regulations.

Pharmacy Compliance Solutions

Develop, implement and maintain proactive, preventative programs to assure compliance and discourage fraud and abuse by your pharmacy staff.

Documentation and Process Compliance

Robust Regulatory Content Management and Flexible Business Process Management to ensure compliance and consistency across your enterprise

Distribution Operations and Efficiencies Reviews

Custom solutions designed to maximize efficiency of your distribution operations

Hospital Compliance Services

Custom programs designed to help you maintain compliance with applicable sections of 21 CFR Part 1300 regulations