AM Technical Solutions (AM) regularly provides Life Science solutions for companies whose projects are regulated by the FDA and other health agencies. We lend our expertise in various ways to help our clients meet the latest industry requirements, including annual recertification support services.
As a global architecture, engineering, and construction firm specializing in high-tech markets, we consistently deliver value to our customers by providing flexibility, visibility, and control throughout these recertification projects.
We are currently supporting a global medical device company whose U.S. facility is subject to an annual review. We will provide commissioning solutions to meet our client’s benchmarks for safety, quality, cost, and schedule so they can maintain operations without disruption.
The Annual Recertification Support Services for Our Client
Our company will provide the following comprehensive services to recertify the facility:
- 3rd Party Testing & Gas Sample Analysis (including Data Summary & Analysis)
- Environmental Sampling & Analysis (including Data Summary & Analysis)
- Facility Certification
- Final Report Support
Because this is a time-sensitive project with aggressive objectives, we will be providing highly qualified personnel to lead the project and work with our client throughout each step of the recertification review.
We know that success in any project is directly related to the quality and skills of the project members and the communication between teams on the ground. Our leaders have assembled a team of Subject Matter Experts (SMEs) with a strong track record and can deliver the right value to the project.
We carefully selected each team member with an eye on communication. We recognize that the highest risk to any project is poor communication, which can lead to costly dollar overruns, change orders, and disrupted plans. Fortunately, our SMEs thrive in environments where collaboration and agile responses to dynamic changes are necessary.
The team will use proven tools, communication strategies, and best-known methods to proactively address any issues before they negatively impact project objectives. By putting our client’s needs first and emphasizing communication, we will help achieve alignment with FDA requirements and industry standards.
“We are confident that our proposed model will help manage the complexity that comes with this type of project and adhere to the project objectives,” says Scott Lessard, VP, Life Science. “We will operate with a ‘first time right’ mentality to mitigate risks and ensure successful completion of the annual review.”
– Find out more about our capabilities to support Life Science facility projects.
– View our portfolio of award-winning high-tech construction projects for Life Science clients.
– Does your company need support for an annual recertification project? Contact us today to discuss our services for your facility.