Compliance Solutions & Consulting Services
Regulatory requirements from State Boards of Pharmacy, the FDA and the DEA can be confusing and difficult to understand. That’s why, in addition to science-based testing and data interpretation solutions, Eagle also offers consulting services in line with regulations including USP <795>, USP <797>, USP <800>.
Committed to Quality
Eagle consultants have over 150 years of extensive experience
Our scientific experts excel at helping sterile and non-sterile compounding facilities identify challenges, risks and opportunities, then discover and implement cost-effective, science-based solutions. With their guidance, you’ll feel confident with your compliance.
Facility Design Review
Planning to renovate your facility to comply with USP <800>? Perhaps you see an opening in the marketplace to begin compounding sterile products. Or maybe, you’ve secured investor funding to open a GMP facility near a metropolitan hospital network. Where do you start? Our facility design team can tailor your ideas to match the specific guidelines & requirements for your operation.
Standard Operating Procedures Development and Implementation
Let Eagle do the work for you! Our team can develop your SOPs so that you can focus on what you do best. Schedule an on-site visit with our consultants and a member of our consulting team will review your processes, notate your daily functions, and spend time conversing with you and your staff to understand how you get things done. Once everything is completed, Eagle will develop customized SOPs for your facility.
Due Diligence Analysis
Looking to enter into an agreement or partnership with a compounding facility? Or are you planning on purchasing an existing compounding business? Let our consultants perform a due diligence analysis to identify any operational, personnel, or compliance-related activities that may require attention.
Operational Flow Analysis and Procedural Review
How will you maximize efficiency within your staff, instruments, and available space? What’s the most
optimal layout for your pharmacy? Will your current configuration inhibit future growth? Our consultants will review your operational flow and make adjustments that help you best utilize your facility space and improve workflow
Mitigation, Remediation and Regulatory Response Services
Whether it’s an FDA inspection, State Board visit, a 483 response, or even worse – a total product recall. When a crisis knocks at your door, you need knowledgeable experts to guide you through the process. Learn more in this video
Support to Pharmacies and GMP Operations
Eagle will help you maintain a realm of protection around your business in the midst of the ever-changing regulatory environment. By staying in front of market trends that occur within the pharmaceutical industry, our consultants will meticulously guide you through the industry challenges that impact your business, your clients, and your livelihood.
Cost-effective Regulatory Solutions
Our compliance experts are committed to helping you achieve your compliance goals in a cost-effective and timely manner.
|Consulting Services*||$250-750 hour|
|503A – USP <795>, <797> & <800>||Starting at $5,000|
|503B & Pharma – 21 CFR Gap Analysis Audit||Starting at $10,000|
|Mitigation, Remediation and Regulatory Response Services||$350-750/hour|
|New Facility Construction Project Management||Quote dependent on scope of work requested|
*Minimum charge is $250 per hour
Download our Consulting Brochure
Ready to Get Started?
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“I’m delighted to be doing business with Eagle”
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 in the representatives I deal with gives me confidence as a pharmacist, and I’m delighted to be doing business with Eagle.
Danny Carrero, Best Pet, RX – New York, NY