On-Site Staffing for Analytical Testing to avoid Regulatory Issues and Market Disruption

Situation: Our client was faced with regulatory commitments and shifting product lines in their manufacturing facilities. This situation produced a critical GMP compliant accelerated demand for analytical testing. Product supply to the market was at risk and regulatory sanctions were a high probability.

Task: Provide additional analytical support to help client avoid regulatory sanctions and avoid product inventory disruptions in the market.

Action: AAIPharma quickly assembled a team of five committed, experienced, well trained and highly motivated analytical chemists. To reduce training and familiarization time, the team performed an initial review of methods and key procedures associated with the clients operations. AAIPharma made all the arrangements to relocate the team to the client's manufacturing location, over a thousand miles away.

Result: The client experienced a significant reduction (over 50%) in product release time to the market while the AAIPharma chemists were on site. The client's personnel were able to focus on training and process improvements that satisfied FDA requirements and avoided future problems. AAIPharma's contract with the client was extended for an additional six months to focus on additional improvements.