Regulatory Compliance Services
Our regulatory compliance experts are trusted industry leaders with the experience and expertise to navigate the evolving compliance requirements of our global marketplace. Our unique compliance design and deployment framework integrates strategic initiatives such as ICH Q9, 10 and 11 with hands-on support of core systems and processes.
Pharmatech is the first choice for organizations which demand intensive technical insight such as personalized medicine, cell and gene therapy drug modalities, innovative API and small molecule drugs, medical device, and combination product device therapies.
Today’s Quality Management Systems require a solid foundation in science, whether auditing an organization for ISO 22716, ISO 13485, ISO 14971 or ISO 27001 compliance to conducting a gap analysis against FDA, PIC/S, WHO or EU standards. From proactively developing phase-appropriate Quality Management Systems for companies transitioning into Good Manufacturing Practices (GMP) manufacturing for the first time to full remediation exercises in response to regulatory health authority inspection action, we have the expertise to strengthen your GxP compliance and minimize your risk position.
Pharmatech’s ecosystem translates to tailored, scalable, efficient, and sustainable Quality Management Systems supporting all aspects of a products lifecycle. Our team-based approach ensures you have access to the subject-matter expertise you require.
QUALITY MANAGEMENT SYSTEMS AND TRAINING PROGRAMS
INSPECTION READINESS AND COMPLIANCE REMEDIATION
QUALITY AUDITS AND RISK MANAGEMENT
ADDITIONAL REGULATORY COMPLIANCE SERVICES