EDUCATION ABOUT OUR SERVICES
cGMP Regulatory Compliance SERVICES
Our ex-FDA expert can provide mock-FDA compliance inspections for pharmaceutical, biotech, dietary supplement and medical device manufacturers and sterile compounding pharmacies. We will determine your level of compliance and provide a report of findings relative to gaps and deficiencies of good manufacturing practices. The audit will provide corrective actions that could prevent your company from receiving FDA-483 Inspectional Observations that may delay manufacturing or sales of your product. We can also provide you with remediation or corrective and preventative action plans (CAPAs) that may help you keep your products safe, unadulterated and in FDA compliance with current good manufacturing practices.
Our Expertise
Big Horn Safety as an ex-FDA specialist, as lead auditor to help improve regulatory compliance for U.S. domestic and international companies. Our expert is a degreed professional having decades of experience in the auditing of pharmaceutical, biotechnology, medical device and dietary supplement manufacturing. Our specialist follows domestic and international standards and guidelines relevant to these FDA-regulated industries. Our auditor also has a pharmacy and biotechnology technical expertise which aids in understanding the relationship between technology and regulatory affairs.
PHARMABLOG
PHARMACEUTICAL TOPICS BLOG
Our blog focuses on educational materials to enhance the knowledge of medication safety and pharmaceutical and medical regulatory compliance.