Resources
Publications
Download The ClinAudits Overview Brochure
This publication will provide an in-depth and comprehensive overview of ClinAudits portfolio of services. Once you have reviewed its contents, should you have any further questions or wish to discuss your current or upcoming audit and/or consulting needs, please contact us. We would be pleased to meet with you.
Download the ClinAudits Risk-Based Auditing eBook
Outside Links
GxP and Regulatory Information Services
The conduct of clinical drug/medical device development, conformity with GCP, GMP, GLP and GTP requirements and guidance, as well as familiarity with standard industry practices can be a complex array of must know issues.
ClinAudits recommends visiting the following websites to gain a further understanding:
- U.S. Food and Drug Administration (FDA) – www.fda.gov
- FDA News – www.fda.gov/opacom/hpnews.html
- Department of Health and Human Services – www.hhs.gov
- FDA – Tobacco Guidance – Click for link
- Submitting Tobacco Health Document Info – Click for link
- CYBER What’s New – Click for link
- CDER What’s New – www.fda.gov/cder/whatsnew.htm
- Product Quality Research Institute – www.pqri.org
- International Association for Pharmaceutical Science and Technology(formerly Parenteral Drug Association) – www.pda.org
- United States Pharmacopeia – www.usp.org
- European Medicines Agency – www.emea.eu
- Drug Information Association – www.diahome.org
- International Conference on Harmonization – www.ich.org
