The Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Title 21 provides guidance for designing and operating a pharmacovigilance program.  Sections that specifically govern this process are:

310.305:  Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 

314.80:  Postmarketing reporting of adverse drug experiences.

314.98:  Postmarketing reports.

Our Quality Assurance group can help guide a client through the Code of Federal Regulations to assure that regulatory requirements are being met.  The QA group can assist the new client by providing guidance regarding what is expected from a regulatory standpoint, from SOPs to documentation control to Corrective and Preventive Action plans.  We work closely with the client to development a Statement of Works that accurately reflects what are doing while ensuring regulatory compliance upfront.  

Our goal is to make you comfortable and confident that your project is compliant with both regulatory agencies and your requirements.