Compliance solutions that improve the quality of life ®

Our team members combine functional & practical expertise to provide our clients with service that delivers impact & results. We deliver value to our clients, partnering with them to solve challenging issues. Read through the highlights of a few of our client engagements.

I. Helping a Fortune 200 company meet its drug development schedule

Situation:

A large biotechnology firm required support in order to implement Phase I and Phase II clinical GMP systems sufficiently flexible to support developmental and operational goals of getting a facility ready for manufacturing. The facility had been built but it was not yet qualified. Prior to our intervention clinical production was being outsourced.

Intervention:

We were able to address facility and equipment issues as well as identify key training areas. We implemented a quality system consisting of over 80 quality documents managing all required systems for production assuring that the appropriate equipment and facilities were qualified in commissioning new manufacturing suites.

Result:

The commissioning of the manufacturing suite was a major component in achieving the firm’s objective in maintaining its drug development schedule.

II. Preparing a mid-sized biotech for FDA inspections

Situation:

A mid-sized biotechnology firm needed a more robust quality management system, including policies, procedures and training material prior to requesting a pre-approval inspection for its manufacturing process to support drug approval.

Intervention:

We implemented a quality system and procedures.

Result:

All personnel were trained in the new policies and procedures and were ready for the FDA inspection.

III. Certifying the clinical studies of a large CRO to the FDA

Situation:

A large CRO had performed hundreds of clinical studies for various clients to support FDA drug approvals. An FDA investigation challenged several of the studies used to support approval causing the agency to question all of the studies conducted by that organization. The FDA gave the client the option of verifying their studies using third party auditors or repeating their studies using another CRO.

Intervention:

In collaboration with a team of consultants, we completed review of about three dozen clinical studies for compliance with the law.

Result:

We were able to certify to the FDA the validity of most of the studies saving the clients $200,000 to $300,000 for each study not repeated.

IV. Helping a foreign distributer to get their products into the marketplace

Situation:

A foreign distributor’s drug product was detained at U.S. entry port.  The product had labeling issues and was not listed with the FDA therefore was not allowed into the U.S.

Intervention:

We reviewed their labeling and acted as their U.S. Agent with the FDA.

Result:

We provided the required information to the distributor in order to facilitate the completion of the distributor’s registration.

V. Reduced risk of substantial FDA fines for a large biotechnology firm

Situation:

A large biotechnology firm received a FDA 483 notice of inspection concerning its procedures for the handling of all written and oral complaints not being followed. Prior to the engagement, there was not a clearly defined procedure on how certain complaints were being handled.

Intervention:

A review of procedures indicated that a change in the reporting category was needed to more clearly define which department was responsible for any particular complaint and to determine why procedures were not followed.

Result:

Procedures were revised, all personnel were re-trained and changes in the reporting category were implemented satisfying FDA expectations. The firm reduced its exposure to substantial FDA fines.