Quality Assurance GxP Consulting
Cost Effective and Experienced GxP Leadership

One of the biggest concerns that the pharmaceutical industry constantly addresses is the safety of its products. The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries.

Acquiring high quality managers and employees, along with the system support that is foundational for quality management raises the company’s expenses over time. Also, with the increasing good practice (GxP) audit obligations, in-house personnel find it difficult to manage intensive, time-consuming, and costly audits as they often entail extensive travel requirements.

The regulatory environment is dynamic and constantly evolving. Quality and regulatory guidance is more than just reading and following the Code of Federal Regulation instructions as they apply to pharmaceuticals, controlled substances, and medical devices. It is often necessary to understand how the governing administration or agency currently interprets its own regulations. The regulation as written may stay constant over time, but how it is interpreted can change significantly. Regulations as written will also change in response to the evolving landscape. This dynamic regulatory environment requires the benefit of experienced industry quality and regulatory expertise to navigate successfully.

QA-GxP Services offers solutions to manufacturers in the GxP space for functioning quality system support by creating and maintaining Quality Management Systems that enhance operations, quality and efficiency while reducing corporate risk exposure and associated cost.

QA-GxP Services support our client companies with ongoing compliance to established standards for processes to ensure product reliability, consistency, and safety. Quality Assurance (QA) failures can cost businesses significant dollars in fines, necessitate recalls, and most importantly - impact the company’s reputation if patients are placed at risk.

“QA-GxP Services helps clients manage a dynamic and shifting compliance landscape, reducing risks and burdens on staff. The company performs QA functional execution by defining and executing systems and processes throughout the manufacturing process and ensuring that the goods and services meet the required quality, efficacy, and safety requirements,” states Alan Smith, Owner of QA-GxP Services.

With business experience of more than 20 years, the company promises to bring executive-level, quality-focused leadership to an FDA-regulated business along with other quality services like hosting and conducting GxP audits, gap analysis, mock inspections and performing due diligence.

QA-GxP Services is focused exclusively on clients’ needs in the pharmaceutical regulated industries and would like to help your business as well.