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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.

Quality Systems Development

Quality Systems are formal documented processes, procedures, and responsibilities that are required to ensure consistent and acceptable results  in both sterile and non-sterile compounding facilities. Learn more in this article.

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.

 

Cost-effective Regulatory Solutions

Our compliance experts are committed to helping you achieve your compliance goals in a cost-effective and timely manner. 

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

Gap Analysis Audit — USP or 21 CFR

This audit is critical in helping discover the “gaps” in your facility, and in identifying the corrections which are needed to ensure USP <795>, <797>, and / or <800> compliance. Learn more

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 crisis knock 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. 

SERVICE
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

Download and print a detailed overview of our consulting services

Ready to Get Started?

Complete the form below to receive a free initial consultation and discuss your operation’s specific needs.

“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