We View Compliance As a Regulatory Journey, Not a Destination
Compliance with regulatory agencies is the core of ProPharma Group’s compliance and quality assurance services. Our experts understand that compliance is what holds the quality assurance structure together, and without it, the QA program can and will eventually collapse.
ProPharma Group is a trusted partner to guide your organization along the regulatory journey. While many compliance consulting companies are eager to identify gaps in your system, our clients find value not only in the expertise we provide to augment their existing capabilities, but also in the partnerships we form with our collaborative approach. With 16 years of experience and industry-leading subject matter experts, our team knows the complex regulatory elements pharmaceutical, biotechnology, and medical device companies face. We understand the compliant systems that need to be in place for your company to prepare for, execute, and address compliance related observations and deficiencies, thus mitigating regulatory risk. From gap assessments to remediation, we work alongside you to proactively help avoid issues with regulatory agencies.
- 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>