Bringing Value, Enhancing Outcomes
Dependable FDA Compliance Services Nationwide
FDA Compliance Services
It is critical to maintain your FDA compliance with regulations and guidance set forth by the FDA and its worldwide counterparts. ASI helps you do that by implementing workable strategies for key areas such as risk management and data integrity. ASI also provides auditing, gap assessments, and quality assurance project management services. Get peace of mind knowing that your business is operating in FDA compliance with all applicable regulations. This is our specialty, so trust us to help.
FDA 483 & Warning Letter Response and Remediation
ASI provides help when you need assistance responding to FDA and its European counterparts’ enforcement actions. We also help with the required remediation efforts.
We help you build a quality system with management in the middle. From technical writing to gap analysis, we guide you every step of the way.
ASI helps your company by guiding clients to integrate the risk management system into your broader quality system.
We use a validation master plan (VMP) to help you document a complex and dynamic system. There are many strategies, and we customize yours.
It’s important to have a functioning quality assurance system in place so your company can comply with the FDA. We help organize and implement that system.
At ASI, we require our clients to have their computerized systems qualified or validated. Our method is based on GAMP5 and provides a pragmatic approach.
Auditing and Assessment
We provide auditing services including vendor audits and mock FDA pre-approval inspections. Our goal is to help you reach your FDA compliance goals.
Increase quality of projects with enhanced project management by documenting, reviewing, updating, reporting, and communicating throughout the process.