Pharmaceuticals and Biotech
In today’s global market, manufacturers of pharmaceutical and biotech products face the challenges of a global supply chain and multi-national clinical trials but are rewarded with international approvals and commercialization. This means the pathways for development are increasingly complex, invoking regulatory requirements beyond those of the FDA.
Jeiven consultants have years of experience with FDA, EMA, and other regulatory agencies and can help you navigate your development project to a successful conclusion. We can guide you through formulation development, regulatory strategy, method development, stability programs…and more. We can support your Quality unit—or even function as your Quality Assurance department. And Jeiven can deliver high-quality customized training to keep your staff sharp and help you maintain compliance with rapidly changing regulations and industry standards.
Jeiven can assist pharmaceutical and biotech manufacturers of all sizes. We can conduct internal audits to identify gaps in your procedures that may expose you to regulatory risk. We can propose new procedures or modifications that will address any ‘hot spots.’ We can outline control processes that are appropriate for the size and scope of your organization. If desired, we can help draft the procedures using your SOP template and format.
Jeiven can also assist your vendor qualification efforts by conducting contractor or supplier GXP audits on your behalf, whether it is a GLP facility or bioanalytical laboratory; a CRO, clinical site, or eDC/IRT vendor; or a GMP supplier, manufacturer, packager, labeler or distributor. We have a network of expert native-language auditors around the world that can simplify audit logistics and reduced travel costs, too. You will receive a thorough audit report detailing the operations of your contractor or supplier and identifying any gaps in compliance. If desired, we can assist in remediation activities resulting from audit observations.
Our expert consultants can support your clinical trials, too. Need help with clinical supplies? We can design packaging, draft labeling, outline a distribution strategy, and oversee operations either internally or at contractors. We can support you at an individual task level, or manage the supplies for a protocol or for an entire program.