Jeiven provides a wide range of consulting services to assist with GMP, GCP, GLP, GDP, and DEA compliance. We work with pharmaceutical, biotech, medical device and dietary supplement companies, as well as government agencies and research universities; and we work from early stage product development through commercialization. Our wide array of consulting services includes:
Clinical Supplies Consulting
Our subject matter experts have extensive experience managing all aspects of a broad range of clinical trials, from small single-center Phase I trials to large, international Phase III trials.
Firms handling controlled drug substances are regulated under 21CFR Part 1300-1321 and must comply with all associated DEA regulations. Our experts include former DEA Diversion Investigators.
Medical Device Consulting
Medical devices are part of our everyday lives; they include simple items such as tongue depressors to complex imaging technology. All devices must be approved by the FDA’s Center for Devices and Radiological Health (CDRH) before they can be sold in the United States; and they are regulated under 21 CFR Part 820. Devices are classified as Class I, II, or III and the regulatory requirements vary for each class.
Pharmaceutical and Biotech Consulting
In today’s global market, manufacturers of pharmaceutical and biotech products face the complexities of a global supply chain and multi-national clinical trials and the rewards of international approvals and commercialization.