From development through commercialization for the pharmaceutical, biotechnology, and medical device industries. These are just a few of the key areas that we can help:
- Establish & deploy virtual pharmaceutical quality systems for clinical and commercial drugs
- Develop, Implement and Maintain Global Quality Systems
- Filings of INDs, IND amendments, CTAs, MAs and other regulatory submissions
- Risk asessment and recommendations regarding alternatives for risk mitigation
- Strategic and tactical support for complex global external supply chain integrations