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- Robust Quality Systems that continuously evolve and improve to conform to current Good Manufacturing Practices, industry regulations and guidances.
- Commitment to providing quality products and service to meet the client's needs
- Effective communication and shared responsibility with the client ensures quality at every stage of the project
- Regulatory compliance and development support from pre-clinical to registration and commercialization
- We assist clients through preparation of:
- Drug Master Files (DMFs)
- CMC sections for Investigational New Drug Applications (INDs)
- New Drug Applications (NDAs)
- European filings
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- Pre-approval Inspection
- General Inspections
- June 2004 - Greenville*
- May 2006 - Greenville*
- June 2006 - Florence*
- March 2008 - Greenville*
- June 2009 - Florence*
- March 2011 - Greenville*
* No 483 issued
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