PharmaLogika
PharmaLogika is dedicated to providing high-quality educational materials and consulting services in the life sciences industry, including pharmaceuticals, biologics, medical devices, and nutraceuticals. They focus on compliance, regulatory affairs, quality assurance, and clinical studies, supporting industry success through education, consulting, and compliance remediation.
Industries
Nr. of Employees
small (1-50)
PharmaLogika
Willow Spring, North Carolina, United States, North America
Products
GxP concise reference series (books)
A collection of concise reference books covering current Good Manufacturing Practices, Good Clinical Practice, Good Laboratory Practice, ICH guidelines, and related regulatory guidance.
Computer system validation concise reference (book)
Concise reference covering computer system validation and regulations relevant to pharmaceuticals, biologics, and medical devices.
FDA inspections and compliance training references (book series)
Titles focused on FDA inspection guides, establishment inspections, investigation operations, and compliance remediation for regulated industries.
GxP concise reference series (books)
A collection of concise reference books covering current Good Manufacturing Practices, Good Clinical Practice, Good Laboratory Practice, ICH guidelines, and related regulatory guidance.
Computer system validation concise reference (book)
Concise reference covering computer system validation and regulations relevant to pharmaceuticals, biologics, and medical devices.
FDA inspections and compliance training references (book series)
Titles focused on FDA inspection guides, establishment inspections, investigation operations, and compliance remediation for regulated industries.
Services
Independent audits, pre-audit inspections, remediation program development, and regulatory reporting support for GxP-regulated organizations.
Design and implementation of quality systems, SOPs, documentation control, QA/QC processes, and compliance training programs.
Clinical study design, global trial execution oversight, investigator brochure development, and related clinical operations services.
Validation of software development lifecycles and computerized systems for compliance with electronic records/electronic signatures regulations and validated LMS deployment.
Manufacturing compliance upgrades, IQ/OQ/PQ management, packaging engineering and validation, and manufacturing process remediation.
Implementation and regulatory alignment of enterprise systems including CMMS and ERP (SAP), plus project management for schedule and change management.
Independent audits, pre-audit inspections, remediation program development, and regulatory reporting support for GxP-regulated organizations.
Design and implementation of quality systems, SOPs, documentation control, QA/QC processes, and compliance training programs.
Clinical study design, global trial execution oversight, investigator brochure development, and related clinical operations services.
Validation of software development lifecycles and computerized systems for compliance with electronic records/electronic signatures regulations and validated LMS deployment.
Manufacturing compliance upgrades, IQ/OQ/PQ management, packaging engineering and validation, and manufacturing process remediation.
Implementation and regulatory alignment of enterprise systems including CMMS and ERP (SAP), plus project management for schedule and change management.
Expertise Areas
- Regulatory compliance and remediation
- Quality systems and QA/QC
- Clinical trial management and clinical operations
- Manufacturing compliance and CMC
Key Technologies
- Validated learning management systems (LMS)
- Computer system validation (CSV)
- Software development lifecycle (SDLC) validation
- Interactive voice response (IVR) systems for clinical trials