Let Our Experience Work For You
Our consulting team is composed of professionals spanning the pharmaceutical industry with expertise in Current Good Manufacturing Practice (CGMP), Quality Control and Quality Assurance, USP <797> Pharmaceutical Compounding – Sterile Preparations, USP <795> Pharmaceutical Compounding – Nonsterile Preparations, and USP <800> Hazardous Drugs – Handling in Healthcare Settings.
Prior to starting with Eagle, our consultants have held positions at the Food and Drug Administration, pharmaceutical drug manufacturers to include contract manufacturing organizations, 503B outsourcing facilities, and traditional compounding pharmacies (503A).
Let our experience speak for itself; it’s not just textbook.
Contact us to set up an initial consultation with our Team and let our experts guide and support your regulatory needs.
Committed to Quality
Our scientific experts excel at helping sterile and non-sterile facilities identify challenges, risks, opportunities, and implement cost-effective, science-based solutions. We take a holistic approach to resolving your needs. With our guidance, you’ll feel confident with your compliance.
EagleShield Consulting Services
Facility Design Review
Our engineering team will guide you through the building design and construction process, whether it be at startup or transition, to ensure that your facility is in compliance with the standards that govern your operations, including:
- Current Good Manufacturing Practice (CGMP)
- USP <795> Pharmaceutical Compounding – Nonsterile Preparations
- USP <797> Pharmaceutical Compounding – Sterile Preparations
- USP <800> Hazardous Drugs – Handling in the Healthcare Settings
We can assist you in determining the optimal layout of your space to maximize efficiency and workflow all while keeping growth in mind.
A quality system is a set of written policies, processes, procedures, and defined responsibilities that an organization must implement to assure that the quality attributes of a finished drug product are consistently met. Let our experts in Quality Assurance and Regulatory Affairs develop your quality management system to comply with regulatory requirements, mitigate the cost of poor quality, and improve patient outcomes. Learn more.
Development and Implementation of Standard Operating Procedures
Operating procedures must be well-defined and specific to your organization. Schedule an on-site visit with Eagle so that a member of our consulting team can visit your facility, assess your current processes, and create written procedures in accordance with the regulatory requirements governing your organization, ensuring that all members of your team understand how to implement and execute your written procedures.
A gap analysis is a comparison between your current compliance status and the regulatory requirements that govern your operation. Our Quality Assurance and Regulatory Affairs Team will review and assess your systems, processes, and documents to identify the gaps in compliance, evaluate the risk of non-compliance, and assist in remediation to ensure that your organization is inspection ready. Learn more
Mitigation, Remediation and Regulatory Response Services
Appropriate responses after FDA or State Board of Pharmacy inspections are critical to the future of your organization. Let our consulting team manage the regulatory response, suggest remediation activities, and support you through the development and implementation of Corrective and Preventive Action (CAPA) plans, to ensure that your organization has the best chance for success. Learn more.
Due Diligence Analysis
A due diligence audit is the assessment of a potential investment that seeks to identify the facility, operational, personnel, or compliance issues prior to proceeding with a transaction. If you are looking to purchase a compounding pharmacy or a manufacturing facility, contact our consulting team to ensure that you are equipped with the information to support your decision-making process.
Download Our Consulting Services Brochure
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“Eagle’s consulting team has been paramount to our company in terms of ensuring compliance with complex state and federal regulations, enhancing operational efficiencies, implementing best practices, and instilling a culture of continuous quality improvement in our team.”
“Eagle has become an integral part of ensuring we deliver safe compounds and maintain the quality that allows us to have trust among pet owners and veterinarians. We utilize a triple-check system to test our compounded medications and rely on their superb service and expertise on a regular basis. The level of competence exhibited by the representatives I deal with gives me confidence as a pharmacist, and I’m delighted to be doing business with Eagle.”