Quality Control

With over 20 years experience developing and testing pharmaceuticals for major pharmaceutical and research organizations, KP's principals and support staff have very extensive scientific background and expertise.  The combined experience, knowledge and troubleshooting capabilities give KP one of the outstanding product development teams in the industry.

KP can provide all of the services required for ANDA submissions, the CMC sections of an IND submission, and NDA support and development. Testing is done to provide our clients with the most rapid turn-around, the most thorough documentation, and the greatest cost-effectiveness possible.

KP is a company dedicated to scientific excellence in drug development and manufacturing. We have the quality you insist upon in a contract development partner.

FDA Inspections:

1) FDA Inspection #1: KPPT was inspected by the FDA (Detroit District) in September of 2001.  NO Form-483 was issued.  This was also our first FDA Inspection since establishment.

2) FDA Inspection #2: KPPT was recently (May 2003) inspected by the FDA (Detroit District). Once again, no Form-483 was issued.  Copies of both the above reports can be provided upon request.

3) FDA Inspection #3: KPPT was recently (Feb 2005) inspected by the FDA (Detroit District). Once again, no Form-483 was issued.  Copies of both the above reports can be provided upon request.