Neozene specializes in bringing California compounding pharmacies into alignment with all FDA, PCAB, California State Board of Pharmacy, and USP (795, 797, and 800) regulations, rules, and guidance documents. We have helped bring numerous compounding pharmacies into compliance with all required requirements (there are dozens!).
Are you aware that attorneys are not process experts and do not know how to validate your processes including cleaning to prevent cross-contamination, and do not know how to configure your compounding areas including the installation and validation of vent hoods? Neozene has validation experts that have decades of experience in the pharmaceutical industry and know how to implement all the requisite changes in your facilities as well as preparing your documentation for USP and FDA scrutiny as well as California State Board of Pharmacy registration and PCAB accreditation requirements.
Neozene will assess your current status, your facilities, and all documentation, and identify any gaps, while helping lead you through the process for achieving full compliance with all requirements. We can also help you to build-out your new facility starting in the planning stage and implementing all your new processes including training of your pharmacy staff. This includes validating your processes and equipment and creating and implementing a quality system compliant with all requirements applicable to you. Neozene consultants have an average of >20 years of experience working in regulated industries and are experts on pharmaceutical regulations.
All Neozene compounding pharmacy projects are overseen by professional Project Managers. These PMs also have access to Neozene’s internal staff of Technical Directors that oversee all projects that Neozene is involved in. This ensures, not only are your PMs well qualified, but they also have unlimited access to all of the experience and knowledge within the TD group as well. This TD group also includes a registered, professional pharmacist that has worked in all aspects of the pharmaceutical business from manufacture to distribution (including pharmacies).
If you think you might be interested in retaining Neozene to help you in your work to comply with the various requirements, please click in the video link here and listen to one of our Technical Directors, Washington Osiro.
The expertise that Neozene brings you can help ease your mind actually improve the efficiency of your pharmacy when we optimize your compounding processes. This helps, not only, to improve your bottom line, but also will ensure you have no issues with cross contamination and protect your own personnel (if you compound hormones, for instance). But don’t take our word for this, read the words from one of our satisfied customers below!