MORIAH Consultants
Regulatory affairs and clinical research consulting firm offering regulatory strategy, submissions support, clinical study design and compliance services to pharmaceutical, device and biotech clients. Services include regulatory planning, preclinical and clinical assessment, GxP compliance audits, medical/technical writing, training, and representation before regulatory authorities.
Industries
Nr. of Employees
small (1-50)
MORIAH Consultants
Nipomo, California, United States, North America
Products
Regulatory Affairs and Clinical Research and Compliance Consulting Services
MORIAH Consultants provides regulatory affairs and clinical research and compliance consulting to the pharmaceutical, device and biotech industries. Services include regulatory strategic planning, preclinical pharmacology and toxicology assessment, clinical study design, clinical compliance audits, review/preparation of regulatory applications, representation and/or liaison with regulatory agencies and scientific groups, and expert witness services.
Design and implementation of GxP Compliance Programs
Consulting service to design and implement compliance programs for Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice.
Clinical Site Monitoring
Service providing monitoring support for clinical sites to ensure compliance with regulatory standards.
Pre-FDA Compliance Audits (GMP/GLP/GCP/PV)
Pre-inspection compliance audits covering GMP, GLP, GCP, and pharmacovigilance to prepare companies for FDA inspections.
GMP/GLP Compliance audits and programs
Auditing and program development services for Good Manufacturing Practice and Good Laboratory Practice compliance.
CRO, Site and Investigator GCP audits
Auditing services for Contract Research Organizations, clinical sites, and investigators to ensure Good Clinical Practice compliance.
Regulatory Affairs and Clinical Research and Compliance Consulting Services
MORIAH Consultants provides regulatory affairs and clinical research and compliance consulting to the pharmaceutical, device and biotech industries. Services include regulatory strategic planning, preclinical pharmacology and toxicology assessment, clinical study design, clinical compliance audits, review/preparation of regulatory applications, representation and/or liaison with regulatory agencies and scientific groups, and expert witness services.
Design and implementation of GxP Compliance Programs
Consulting service to design and implement compliance programs for Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice.
Clinical Site Monitoring
Service providing monitoring support for clinical sites to ensure compliance with regulatory standards.
Pre-FDA Compliance Audits (GMP/GLP/GCP/PV)
Pre-inspection compliance audits covering GMP, GLP, GCP, and pharmacovigilance to prepare companies for FDA inspections.
GMP/GLP Compliance audits and programs
Auditing and program development services for Good Manufacturing Practice and Good Laboratory Practice compliance.
CRO, Site and Investigator GCP audits
Auditing services for Contract Research Organizations, clinical sites, and investigators to ensure Good Clinical Practice compliance.
Services
Regulatory planning, pre-submission review, drafting and compilation of clinical and marketing applications for multiple regions.
GMP/GLP/GCP and pharmacovigilance audits, pre-inspection readiness, and design/implementation of compliance programs.
Study design, clinical operating plans, site monitoring and investigator/CRO GCP audits to support trial conduct and data quality.
Preparation of SOPs, investigator brochures, protocols, informed consent forms, study manuals, integrated study reports and regulatory submission documents.
Courses and seminars on regulatory affairs, clinical quality assurance, preparing for inspections, HIPAA in clinical trials and ethical oversight.
Representation at regulatory agency meetings and liaison services to communicate technical and regulatory positions to authorities.
Regulatory planning, pre-submission review, drafting and compilation of clinical and marketing applications for multiple regions.
GMP/GLP/GCP and pharmacovigilance audits, pre-inspection readiness, and design/implementation of compliance programs.
Study design, clinical operating plans, site monitoring and investigator/CRO GCP audits to support trial conduct and data quality.
Preparation of SOPs, investigator brochures, protocols, informed consent forms, study manuals, integrated study reports and regulatory submission documents.
Courses and seminars on regulatory affairs, clinical quality assurance, preparing for inspections, HIPAA in clinical trials and ethical oversight.
Representation at regulatory agency meetings and liaison services to communicate technical and regulatory positions to authorities.
Expertise Areas
- Regulatory strategy and submissions
- GxP compliance and auditing (GMP/GLP/GCP/PV)
- Clinical trial design and monitoring
- Medical and technical writing for regulatory submissions
Key Technologies
- Regulatory submission drafting and compilation
- Clinical protocol development
- GxP auditing methodologies
- Clinical site monitoring