If you'd like to know where you stand with the FDA or ISO implementation before the Inspectors perform an inspection onsite, or if you have an issue with an FDA / ISO regulation, we can perform an audit at your location to identify the issues.
Our team of Lead Auditors and consultants with decades of experience, as well as industry experts and subject matter experts.
We can audit specific areas of your operation or provide a comprehensive review of your entire system. We'll audit against current FDA regulations and provide gap analysis, including how to correct gaps.
In addition to auditing your facility, we can also perform the following audits on third party facilities, vendors / suppliers, and contract manufacturers.
- GMP audits (Good Manufacturing Practice)
- 21 CFR part 820 audits
- 21 CFR Part 211 audits
- 21 CFR Part 111 audits
- EN ISO 13485:2016 audits
- MDSAP audits
Industries we serve are the following:
- Food Supplements / Dietary supplements
- Drugs / Pharmaceuticals / Active Pharmaceuticals
- Homeophathic drugs
- Medical Devices
EUROCERT can do QMS audit on your critical suppliers for GMP practice and regulatory requirement. We can pre-inspection audit for those anticipating an FDA inspection.
Fees:
- Onsite GAP Analysis with Report – 500 Euro /man-day
- FDA 483 response preparation and guidance for closing each 483 - Euro USD
- ISO 13485:2016 Internal Audit – 300 Euro
- MDSAP GAP Analysis – 600 Euros per man-day
- Travel & Lodging and taxes Extra.
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