Good Manufacturing Practice (GMP) Audits
Quality Risk Management Guidance
Mock-FDA Inspections
Big Horn Safety has the regulatory and manufacturing auditing expertise required to help your drug, biotech, pharmacy, supplement or device company maintain compliance with Federal regulations and International guidelines. We will conduct an independent audit of your manufacturing process, identifying problem areas and providing feedback for corrective and preventative actions. This will provide you a snapshot of your baseline compliance so that your business may be on its way to be successful and free from regulatory action by FDA.
Our experts provide auditing services to assess if your products are manufactured under current Good Manufacturing Practices (cGMPs). Big Horn Safety will work with you to review all pertinent manufacturing systems and processes to help you comply with federal regulations.
Big Horn Safety can also provide guidance on risk management tools to help you build and maintain a Quality Risk Management system. A good Quality Risk Management system will assess the risks to the quality of your product across its life cycle and provides a risk-based corrective action plan.
Big Horn Safety can also provide a mock-FDA inspection to prepare you for the real one. This service will provide your company with extra confidence that the FDA may leave with no FDA-483’s or other non-compliance observations issued that could disrupt sales of your products..
Big Horn Safety auditing services provides expertise to the following FDA-regulated industries:
Please click on the specific industry listed above for more detailed information. Big Horn Safety experts are here to serve your company's regulatory compliance and safety needs.
GMP Regulatory Compliance SERVICES
Our ex-FDA expert can provide mock-FDA compliance inspections for pharmaceutical, dietary supplement and medical device manufacturers and sterile compounding pharmacies. We will determine your level of compliance and provide a report of finding 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 could delay manufacturing or sales of your product. We can also provide you with remediation or corrective and preventative action plans (CAPA) to keep your products safe, unadulterated and in FDA compliance with current good manufacturing practices.
