Our Regulatory Experts Can Help
Does your compounding facility need help with USP <795>, <797>, and <800> compliance? Do you need assistance with PCAB®- accreditation? Let our experts conduct a Gap Analysis at your facility to determine compliance with compounding regulations and standards.
What Is A Gap Analysis?
This assessment is a survey of systems and documents that according to industry regulations should be in use at your facility.
What Are the Results?
Identified areas of improvement are considered “gaps” and should be proactively addressed and corrected to ensure compliance and avoid the burdensome cost of remediation.
Our experts will assess equipment, personnel, and procedures and identify all areas that need to be corrected in order to meet the requirements of USP <795>, <797>, and <800>
When you schedule your audit, an Eagle consultant will come and spend time at your facility working with you to improve the quality of your operation and to ensure your processes are in line with regulatory expectations. Our mock FDA inspection allows you to make corrections ahead of time so that you’ll feel confident in the event of an inspection.
503A or 503B....Not Sure Where You Fall?
You’re not alone. Many compounding facilities are unsure about FDA’s 503A exemptions as well as other requirements including FDA’s Insanitary Guidelines.
Our consultants will help you make certain that your operation complies with FDA requirements. You’ll feel confident knowing that you’re backed by a team with over 200 years of combined experience.
Hundreds of Satisfied Customers
My team and I have developed a great partnership with Eagle and their dedication to helping us with testing and consulting exceeds every expectation. Their consultants spend a lot time getting to know our company and what we need, while making it very personable. If you are looking for testing or consulting, Eagle is who to go to
My experience with Eagle has been nothing short of exceptional! Their professionals have years of experience and are very knowledgeable about the industry. I am especially impressed with the high level advice from Ross and the consulting team, as well as their guidance relating to organizational compliance and business growth. I highly recommend Eagle for any of your testing or consulting needs!
Pricing & Information
Our compliance experts are committed to helping you achieve your compliance goals in a
cost-effective and timely manner.
GAP Analysis Audit(Pricing below does not include expenses)
- 1-2 day audit assessing:
- Environmental Monitoring
- Aseptic Processing and Technique
- Documentation System
- Training Records
- Process Control
- Finished Preparations Testing
- Quality Assurance Program
GAP Analysis + Implementation Service
- Complete development of your customized Standard Operating Procedure (SOP) Manual
- Complete set-up of your environmental monitoring program
- Training on proper aseptic practices including proper gowning and gloving techniques
GAP Analysis Interest Form
We’re glad to help. Let’s get started. Fill out the form below in order to help our team better understand your requirements.