GMP/GLP/GCP Compliance
MORIAH's clinical compliance service facilitates and supports
the successful completion of your manufacturing operations, nonclinical and clinical studies. Our staff
draws on their in-depth knowledge of FDA and worldwide GMP/GLP/GCP regulations
to assure that your clinical studies meet the highest standards
and fully comply with all regulations. MORIAH has global experience with drug,
device and biologic products and their compliance. Our auditors provide comprehensive
monitoring and auditing support capabilities to ensure that your
data and supporting documentation are complete accurate, factual
and in the appropriate format for company and regulatory authorities.
In addition, MORIAH can provide support to your company in the
review and preparation of Standard Operating Procedures (SOPs)
and training and education programs for your staff on all aspects
of Regulatory Affairs, Quality Assurance and GMP/GLP/GCP/PV Compliance.
Compliance Services
- Clinical Site Monitoring
- CRO, Site and Investigator GCP audits
- Design and implementation of GxP Compliance Programs
- HIPAA Compliance and Clinical Trials
- Part 11 (Electronic Records) Issues
- Review and Preparation of SOPs
- GMP/GLP Compliance audits and programs
- Pharmacovigilance (PV) compliance audits
- Pre-FDA Compliance Audits (GMP/GLP/GCP/PV)
Training and Educational Seminars and Courses
- Regulatory Affairs
- Clinical Quality Assurance
- Preparing for a FDA Inspection
- Role of HIPAA in Clinical Trials
- Ethical Oversight in Clinical Trials
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