Our up-to-date knowledge of regulatory requirements in Pharmacovigilance and Risk Management provides clients the necessary support to sustain compliance. We work with clients to both prevent and remediate compliance issues, taking into account the interplay of process, technology and organization.
Implementing New Regulatory Requirements
The regulatory landscape is continually changing. Therefore, staying up-to-date with new regulatory requirements is crucial to achieve compliance. We work alongside clients to identify key changes affecting their operations and support them in implementing effective strategies to meet those requirements.
Preventing Audit and Inspection Findings
Regulatory inspections and audits are an essential part of evaluating the compliance of life sciences companies. We identify any gaps in compliance with regulations before inspections and audits occur, allowing our clients to address and correct any issues. Our team also provides guidance to our clients in preparing for inspections and audits, including conducting mock audits and identifying potential risks.
Closing out CAPAs Effectively
At Truliant, we excel at systematically closing out issues through effective corrective and preventive actions (CAPAs). Our consultants are dedicated to rolling up their sleeves and getting their hands dirty to help clients navigate every step of the CAPA process. From identifying the root cause of an issue to developing a robust corrective action plan, we work closely with clients to ensure timely and effective closure of CAPAs. We also provide valuable assistance in preparing and reviewing documentation, including reports and plans, to guarantee the thorough resolution of the issue at hand.