Consulting Services

If your company has a regulatory inspection audit coming up, make sure you are ready by having a pre-audit by one of our experienced consultants. We help get sites ready for inspections, including working with groups to get their own areas ready.  We can also assist behind the scenes during the inspection itself. The cost and time associated with regulatory re-audits, if an audit outcome is not sufficient, can also be avoided or minimized.

ESOPTRON frequently executes validation projects consultation on a fixed price basis. After many years of working in validation our experts have gathered a formidable library of key project documents, ranging from Validation Master Plans and Functional Specifications (FS), so we can comfortably and efficiently gather and document your key requirements. 

Whether it is a pharmaceutical company or a clinical laboratory facility; our experts can navigate their way through the regulations and help you set up a compliant and practical validation approach and you can have confidence.

We can provide an independent GLP review to make sure that all the important details at your laboratory are covered.

ESOPTRON’s consultants will conduct an ISO 15189 Compliance Audit as if they were doing so for a regulatory body, but coupled with friendly advice on how to fix your laboratory problems. We can help you build a road map on how to enhance your facility and QMS to ensure compliance.

The Quality Management System (QMS) is usually the first place a GMP/GLP auditor will ask to see during inspection prior to the accreditation process. 

We know that the basic rule in QMS is to “say what you do and then do what you say”. This means that your QMS must document the processes used in your facility and also demonstrate that the employees are following those documented procedures.

Our Consultants will redraft or perform a final review of the documents your staff have prepared.