Project and Site Evaluation
Our team offers project evaluation for entire projects or individual steps, including planning, organization, partner selection, coordination, monitoring, and controlling of development processes.
With a team of highly experienced experts from the FDA and industry, we offer a wide range of mission-critical services to the highly regulated pharmaceutical industry. We work with our partners to design and implement effective and efficient business processes that assure sustainable compliance through optimal integration of scientific, technical, and regulatory principles. As is equally important, Cadence Hub helps its partners to stay current with the ever-changing regulatory and technical environment, as well as with evolving industry practices.
Project/Site Evaluation has been broadly classified as:
- Site for M&A that includes technical and marketing due diligence
- Site for CMO that includes technical and supply chain due diligence
Cadence Hub works with diverse companies and is proud of their accomplishments. The list below provides a high-level overview of how we can support your needs:
- Provide expert consultant services for development and execution of numerous remediation/voluntary corrective action plans, which would be accepted by the FDA
- Provide due diligence activities during the pre-purchase phase for multinational companies and marketing applications
- Perform specialized audits and consultations
- Perform application integrity audits
- Facilitate greenfield and brownfield projects