Jeiven has provided consulting services to pharmaceutical and biotech companies for more than 30 years. Our clients come back to us because they know we will provide them with the highest level of service. The hallmark of our success has been our outstanding customer satisfaction and client retention.
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. This means the pathways for development are increasingly complex, invoking regulatory requirements beyond those of the FDA.
Our team of experts has provided strategic advice to clients of all sizes from small, virtual start-ups to large pharmaceutical firms and can help you navigate your development project to a successful conclusion. Our team has years of experience with FDA, EMA, and other regulatory agencies.
We can guide you through formulation development, regulatory strategy, method development, and stability programs…and more.
Areas of consulting expertise include:
- Pharmaceutical/biotech product development
- Assist with strategy planning to move product forward
- Analytical method development and validation
- Process improvement
- Design stability studies and shelf-life assessment
- Formulation development and scale-up
- Review method development and validation
- Equipment qualification (IQ/OQ/PQ)
- Advise on steps needed for robust, approvable filings including:
- Review CMC sections
- Advise on technical sections of INDs, NDAs, ANDAs, BLAs, 505(b)(2)s
- Review IND/NDA annual reports
- Review Annual Product Reviews (APRs)
- Clinical Supplies Project Management
We can support your clinical supplies activities and design packaging, draft labeling, outline a distribution strategy, or oversee operations either internally or at contractors.
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- Quality Assurance (QA) and Quality Control (QC) Consulting:
We can support your Quality unit—or even function as your Quality Assurance department.
Learn more about our Quality services
Jeiven’s global team of auditors can assist your vendor qualification efforts by conducting contractor or supplier GXP audits on your behalf.
Learn more about our auditing services
- DEA: Controlled Drug Substances
If your products include controlled drug substances, you have another layer of compliance to contend with – DEA compliance.
Learn more about how we can support your controlled substance activities