COMPLIANCE

When on a project; our team will first align themselves with your company's policies and procedures. Our senior and principle associates will provide process improvements to your  programs through Gap Analysis.

​Our staff also stay current with associated Agency guidance.

Quick Links to Agency Sites

FDA (Food and Drug Administration):
- Quality Systems Regulations
- Quality Systems Inspection Techniques (QSIT)
- Corrective and Preventive Actions (CAPA)
- Search - FDA Code of Federal Regulations Title 21
​- 21 CFR part 11 
​- 21 CFR 820 
- FDA Consumer Updates (Drugs)
- Drugs Site
- Drug Information (Drugs@FDA)
- Recalls, Market Withdrawals, & Safety Alerts
- Vaccines Blood and Biologics (CBER)
- Enforcement Actions (CBER)
- Medical Devices Site (CDRH)
- Radiation Emitting Products (CDRH)

We at TCS-GxP regularly review FDA - Warning Letters to evaluate potential issues that may affect your business.

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ISO (International Organization for Standardization)
- ISO-13485   2003

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USP (United States Pharmacopeia)
- USP Meetings & Courses Page

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NIST (National Institute of Standards and Technology)
 - NIST Site

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ICH (International Conference on Harmonisation)
-  ICH Site
Specifically for technical requirements for registration of pharmaceuticals for human use. This is a group consisting of the US, Japan and the EU regulatory authorities and experts from the pharmaceutical industry.

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ISPE
- ISPE Site
- ISPE Glossary

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MHRA (Medicines and Healthcare Products Regulatory Agency)
- MHRA Site
- Search - Help Glossary

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WHO (World Health Organization)
- WHO Site

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MedDRA (Medical Dictionary for Drug Regulatory Activities)

-  MedDRA SITE
Internationally accepted medical terminology for use in drug regulation. Developed under the auspices of the ICH and based on MEDDRA which was in turn based on the MHRA's medical dictionary.

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