Compounding Quality Assurance Services

Quality Management Systems Overhaul

Are you struggling with several deviations, non-conformance, or out of specification results? Has the Board of Pharmacy cited you with a mandated plan of correction or has the FDA issued you a form 483 or warning letter? Analytical test failures or regulatory citations could be a symptom that your quality management system needs to be overhauled. Our experts can create a system that builds quality into your operations so that safer, high quality compounds are produced. Let us take a holistic approach to investigating the cause(s) of the out of specification results, test failures, or regulatory citations. We can create robust corrective and preventative action (CAPA) plans to address the deficiencies and implement them so you can get back to doing what you do best - compound pharmaceuticals.

Adverse drug event reporting & recall support

Has a recipient of your compound suffered an adverse drug event? Has sterility assurance of a large batch been found to be compromised? Restore Health Consulting can help you through these nightmares. Our consultants have extensive experience in handling and reporting adverse events and recalls quickly. We also excel at writing the reports and press releases in such a way that defends your commitment to safe quality compounding practices, thereby mitigating unnecessary regulatory backlash. Your report or broadcast must be submitted quickly, don’t wait too long to contact the right team to get you through this situation.