GCP QA Expertise

GXP Consulting can provide highly experienced auditors and GCP consultants as follows:

✤ Our auditors has an average of 15 years GCP QA experience and has conducted thousands of audits in all therapeutic areas, according to international and national regulations, in over 100 countries. With clinical trials being conducted globally in various cultures and the complexity of clinical trials the conduct of GCP quality audits is becoming an increasingly challenging process, owing to the location of investigator sites. It is common for investigator sites to be located in Eastern Europe, Asia, Africa, South America, the Middle East and the Far East. Our experienced auditors are adept at functioning in diverse cultures.

✤ GCP QA expertise to you throughout your development lifecycle to ensure that you have the required GCP QA Compliance oversight in your clinical programs. We can help you navigate and implement the clinical compliance regulations that is required by the Global Regulatory Agencies such as FDA, EMA, PMDA, TGA etc. With the lack of adequate GCP QA expertise in the biotech industry, which often results in regulatory actions agains the sponsor, we will provide the GCP QA expertise you need from Concept to Commercialisation™ to ensure this is averted.