Compliance Service Offerings
Our compliance experts conduct audits worldwide and have extensive experience auditing in the United States, Canada, Europe and in countries in Asia. In addition to conducting audits, our compliance team can act as a remote quality unit and provide on-site training programs to help you ensure continued compliance with regulatory agency requirements. Our auditors are specialists who understand the regulatory impact of compliance activities. They do not simply take a check-list approach.
Good Manufacturing Practices (GMP) Services
DSI is a Leader in Regulatory & cGMP Services providing comprehensive, hands-on GMP Quality Compliance services to the pharmaceutical, and biotechnology industries. Our staff have been providing GMP consulting services to clients worldwide for the past 30 years.
Benefits of Having a GMP Consultant
GMP Consultants can bring expertise and experience that your business does not have. They can help manage and complete a compliance project that requires specialized skills or help get work done efficiently.
Our GMP Compliance Experts
You can expect a partner that will not only be hands-on, but will also work alongside you to provide quality compliance services as well as the strategy and training to help you improve your quality systems, thus mitigating future risk. We have consulted with companies of every size on every continent supplying them with viable and efficient GMP Compliance solutions. DSI takes a proven, active approach to listening and addressing our clients’ specific needs to ensure their quality and regulatory operations are in compliance with current industry standards, as well as FDA and global health agencies.
Quality Assurance Services
DSI has managed operational Quality Assurance functions for biopharmaceutical companies in all stages of development, as well as commercial operations. We have provided management of quality investigations, deviations, out-of-specification testing, change control, commercial complaints, and batch record review and release. In addition, we have facilitated QA review of CMC documentation including manufacturing process development protocols and validation reports, product specifications, manufacturing master records, and test methods.
Design, Implementation and Remediation of Quality Systems
Efficient and well-designed quality systems and appropriate development-stage implementation ensure that the expectations of regulators, sponsors, and investors are met. Many companies have unique needs that are best managed using customized quality systems and standard operating procedures. We develop or review Quality Management Systems to ensure compliance for a company’s current stage of operation.
Vendor Qualification, Inspections and Mock Pre-approval Audits
Proactive initial and routine evaluation of vendor cGMP compliance minimizes the risks of quality issues and supply chain disruptions. It also reduces the potential for health authority actions such as 483s, compliance observations, warning letters, market restrictions, consent decrees, etc. Preparing in advance for preapproval inspections demonstratively assists in the avoidance of surprises during the approval and launch process. We identify, remediate, and help to minimize the impact of compliance issues, which can cause costly stock out or delays in commercial approval.
Management of Compliance Situations
When compliance issues are encountered, it is critical to rapidly identify and understand the root cause, develop an appropriate and sufficient corrective action plan, and effectively communicate with the involved parties. Missteps in the handling of potential recall situations or in responding to regulatory compliance observations can lead to increased scrutiny, supply chain disruption, delays in approvals, and the loss of confidence of patients, doctors and investors. We assist in the management of critical compliance situations and provide meaningful, sustainable remediation guidance.