FDA Compliance Services

 

Complying with regulations and guidelines established by the FDA and its global partners is important. ASI can help with this by implementing practical strategies in key areas such as risk management and data integrity. ASI also provides audit, gap assessment, and quality assurance project management services. Rest assured knowing your company complies with all applicable regulations. This is our area of ​​expertise, so you can rest assured that we are here to help.

FDA Response and Remediation

ASI provides assistance when you need assistance responding to enforcement actions by the FDA and its European partners. We can also help with any necessary renovations.

Quality System

We will help you build a quality system centered on management. From technical writing to gap analysis, we'll help you every step of the way.

Risk Management

ASI supports your business by helping you integrate risk management systems into your broader quality system.

Validation

We use a Validation Master Plan (VMP) to help document complex and dynamic systems. There are many strategies and we will adapt your strategy.

Data Integrity

It is important that companies have a functioning quality assurance system in place to help them comply with FDA requirements. We will help you build and implement this system.

Software Certification

ASI requires customers to have their computer systems certified or verified. Our method is based on GAMP5 and provides a practical approach.

Audits and Evaluations

We provide audit services such as supplier audits and mock FDA pre-approval inspections. Our goal is to help our customers achieve their FDA compliance consultant goals.

Project Management

Improve project management and improve project quality through documentation, reviews, updates, reporting, and communication throughout the process.