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PHARMA INDUSTRY REGULATION1PHARMA INDUSTRY REGULATIONHCA 375 Continuous Quality Monitoring & AccreditationPHARMA INDUSTRY REGULATION2IntroductionPharmaceutical research spans over 12-15 years before the pharmaceutical organizationscan come up with a marketable product after seeking the necessary approvals from theregulators. The companies in the process need to invest billions of dollars into the researchprocess from molecule to market. The value of a pharmaceutical drug consists pre-clinicaldevelopment, clinical development, pharmacovigilance& safety through manufacturing andfinally sales and marketing. Given the large number of research activities being undertaken bythe pharmaceutical organizations and large number of molecules usually being considered forresearch, the organizations are usually not in a position to cover all these activities bythemselves. Therefore they need to outsource some of the activities from the value chain toexternal organizations. Pharmaceutical organizations therefore work with a large number ofexternal partner organizations who help them deliver different services in the life cycle.The following paper looks at how one set of such external organizations called as ClinicalContracted Research Organizations (CROs) partner with the pharmaceutical organizations andwhat are the usual set of services delivered by them. The paper also looks at how these CROs areregulated by the FDA and the typical laws that come under the purview of

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