Regulatory Compliance and Remediation
Regulatory compliance issues can manifest in various ways. Internal compliance audits, regulatory agency inspections or manufacturing investigations can highlight gaps that must be resolved to maintain cGMP compliance. This can be a demanding process that must be completed expeditiously to minimize product and business impact.
We have compliance experts that have experience with remediation of a broad range of compliance issues. Our straightforward, proactive approach utilizes internal stakeholders to organize, define root cause, plan, execute and close compliance gaps. This process is designed to limit product impact and provide timely resolution to compliance issues.
Some of the services we have provided our clients include the following:
483 and Warning Letter Remediation,
Consent Decree Remediation,
Regulatory Gap Analysis,
Periodic Review and Trending of Manufacturing Investigations,
Policy and Procedures Enhancement,
Data Integrity Gap Analysis and Remediation