Commitment to Quality

We are committed to producing the
highest quality products possible

As a leading manufacturer of commercial active pharmaceutical ingredients, clinical trial materials and advanced intermediates for Life Science companies, we have always prided ourselves in our Quality Assurance and Quality Control organizations. With six successful FDA inspections and three pre-approval audits of all three of our cGMP facilities, we are positioned stronger than ever.

We are committed to producing the highest quality products possible. We have many systems that work together to ensure that all of our products meet and/or exceed their specifications. Quality assurance is a crucial part of producing products that meet their specifications. This is accomplished by having the correct documents in place so that all parts of a process run smoothly and correctly, by checking finished documents for errors or deviations, and by ensuring that all needed testing is completed and documented.

Quality Compliance

Proven Ability to Navigate Regulatory Process
- cGMP manufacturing status
- 10 DMF submissions
(4 already approved by the FDA)

Harmonization Around ICH
- ICH Q7A compliant

FDA Audits:
- Site Annual GMP Inspection:
  - Newburyport: April 2006
  - Devens: October 2005; June 2008
  - Leominster: February 2002, November 2003, December 2004
- Pre Approval Inspection (PAI):
  - October 2002, October 2005 and April 2006