Compliance and Remediation Services
Implementing Corrective Solutions that Mitigate Compliance Deficiencies
Compliance with regulatory agencies is the core of ProPharma Group’s compliance and remediation services. As such, we share a common goal with our clients: to maintain and elevate the stature of your quality system and ensure conformity is achieved.
By diligently executing proactive measures, such as routine quality management systems audits and enhanced supplier management services, together we will increase the robustness of your underlying quality management system (QMS).
While a proactive and prescriptive approach to maintaining quality should be everyone’s focus, infractions can and will occur that result in 483 observations, Warning Letters, and even Consent Decrees. When that time comes, ProPharma Group will help your organization implement lasting change to remediate the infractions.
With 17 years of experience and industry-leading subject matter experts, our team recognizes that problems rarely begin and end with the QMS. Symptoms often persist in other functional areas of the organization, including manufacturing, validation, and quality control. This is where ProPharma Group excels, as we have the capability to assemble a multi-discipline team, which develops and executes a customized remediation plan, ultimately bringing you back into production as quickly as possible.
- Third-party GMP consulting and GLP compliance auditing
- Mock FDA/international regulatory agency inspections, and PAI readiness
- Due diligence compliance inspections, audits, and assistance
- Qualification and validation
- cGMP training
- Response and remediation support (FDA 483 observations, warning letters, consent decrees, etc.)
- GMP and Drug Quality and Security Act (DQSA) assessments
- Compliance audits for GMP, USP <795>, and USP <797>