About Us
You need help; we can help!
- Quality Improvement Initiatives (Enhancement of Quality System)
- Fix the system or the process and the quality results will come by design
- Success requires planning, analysis and flawless execution
- Preparation for regulatory inspections.
- The success of a regulatory inspection requires careful planning, analysis, flawless execution and attention to details
- Do not leave important elements to randomness
- You can plan and design for success
- Process investigations
- Robust investigations are a must
- Compliance to cGMP in Laboratory Operations
- Laboratory investigations
- Evaluations of technical reports
- CAPA
- Robust CAPAs should minimize errors, incidents and failures
- Annual Product Review
- Develop and compliance with a robust program
- Management Review
- How to develop a robust program
- Data Integrity Program
- Data Integrity and Documentation practices
- Supplier Quality Management Program
- Contract Laboratory Program
- Documentation review on-site and off-site
- Warning letter management and recovery
What is unique from our services?
- Hands on experience
- 40 years; more than 250 regulatory inspections and audits
- Vast experience in multiple technologies
- biotechnology, sterile products, tablets, capsules, liquids, ointments, creams, suppositories, drug substances, combination products
- Integrated process understanding
- Managing for success
- multiple regulatory inspections with no observations inspections
- Recovering from Warning letters
- Managing international markets and regulators
- FDA, EMA, HPB, PMDA, Cofrepis, ANVISA, China, Taiwan, Middle East, TGA (Australia),
- Combination products experience
- Developing a robust Data Integrity Program
Go Ahead - Contact Us
Feel free to give us a call for more information on our services