Audits, Supplier Quality & Inspection Readiness

“We can provide audit support to help ensure that your medical device company meets all necessary regulatory requirements and guidelines, including FDA audits, Notified Body…”

“Halloran offers virtual or on-site inspection and audit readiness engagements to assist clients in preparing for regulatory inspections from agencies such as the FDA, EMA, MHRA…”

“If you are an early-stage biotech, we help you get ready for inspections and can step in as interim Head of Quality when needed. For small pharma companies, we align your systems…”

“Regulatory inspection preparation (FDA, EMA, Swissmedic, global agencies)”

“Review of responses and support for remediation in response to FDA 483 and warning letters”

“Remediation Support, including review of responses and support for remediation in response to FD483 observations, warning letters or consent decrees including independent third…”

“StarFish provides independent reviews and mock audits, giving clients early visibility into risks”

“Maximize compliance and inspection readiness by tapping into IQVIA's "High IMPACT" strategies, technologies, and specialist services”

“Clarkston can assist with performing gap analyses to determine what information and actions are required, managing the plan to ensure all known tasks are completed, and providing…”

“It provides faster time to value with streamlined processes for handling complaints, deviations, audits, quality risk management, supplier quality management, and change control.”

“CluePoints' clinical specialists bring decades of hands-on industry experience to every engagement, from Risk-Based Quality Management (RBQM) framework design and platform…”

“Vendor & Facility Audits Ensuring partner facilities meet required standards for quality and compliance.”

“Inspection readiness and remediation: Ensuring your organization, vendors, and sites are prepared through all stages of development, preventing holds, information requests, and…”