Our Services
APQR
Batch Record Review
Audits
Ensuring that your APQR program is compliant with all applicable regulations and that your APQR report is comprehensive and accurate.
Audits
Batch Record Review
Audits
We assist with all aspects of audits, including identifying applicable audit types (GLP, GCP, GMP, GDPR, HIPAA), developing audit readiness programs, providing on-site support during audits, and managing post-audit follow-up with corrective actions and communication.
Batch Record Review
Batch Record Review
Batch Record Review
We provide compliant batch record reviews covering all manufacturing, testing, and packaging steps. We also help develop review procedures, verify accuracy and compliance, resolve discrepancies, and report findings to regulatory authorities.
Batch Release
Batch Record Review
Batch Record Review
Focused on helping your company to release batches of products in a compliant, efficient, and timely manner. Developing and implementing a batch release procedure, reviewing batch release data and documentation, reporting batch release decisions to the regulatory authorities and more.
CAPA
Change Control
Change Control
We help develop, implement, and maintain effective CAPA systems, including procedures, investigations, root cause analysis, corrective actions, and regulatory reporting.
Change Control
Change Control
Change Control
We help pharmaceutical companies manage change control by developing programs, conducting risk assessments, implementing changes, monitoring impacts, and ensuring regulatory reporting.
Data Integrity
Change Control
Data Integrity
Is your data compliant with ALCOA++ requirements? We help ensure data integrity throughout the product life cycle by developing programs, conducting audits, remediating issues, and training employees to meet regulatory standards.
Deviation
Change Control
Data Integrity
We help with deviation management by developing programs, investigating root causes, assessing risks, implementing corrective actions, and ensuring regulatory reporting.
Document Control
Inspection Logistics
Inspection Logistics
We assist pharmaceutical companies with document control by developing procedures, training employees, auditing systems, and ensuring compliance with ALCOA+ standards to prepare for regulatory inspections.
Inspection Logistics
Inspection Logistics
Inspection Logistics
We help pharmaceutical companies navigate regulatory inspections by planning and scheduling, preparing documentation, supporting during inspections, and following up with corrective actions and communication.
Material Management
Inspection Logistics
Material Management
We help pharmaceutical companies manage complex material logistics by assisting with planning, procurement, storage, distribution, inventory management, and quality control to meet regulatory requirements and ensure product integrity.
Product Complaint
Inspection Logistics
Material Management
We help investigate and manage product complaints by developing systems, identifying root causes, implementing corrective actions, and ensuring regulatory reporting. Additionally, we assist with audit readiness, providing support during audits, and following up with corrective actions.
Quality Management Review
Quality Management Review
Quality Management Review
We help ensure compliance through effective QMRs by planning, conducting reviews, identifying improvements, and implementing corrective actions. Our services also reduce quality risks, improve efficiency, and enhance customer satisfaction and reputation.
Supplier Quality
Quality Management Review
Quality Management Review
We help pharmaceutical companies manage supplier quality by offering expert, objective assessments, developing tailored risk-based systems, and improving efficiency through audits, performance monitoring, and issue remediation.
Training
Quality Management Review
Validation
We offer virtual and onsite training support, including job description updates, role-based curriculums, on-the-job training, customized programs, eLMS implementation, and training assessments to ensure employees are well-prepared for their roles.
Validation
Quality Management Review
Validation
We help ensure process, system, or equipment validation by developing plans, conducting studies, analyzing results, and preparing validation reports to confirm product quality, safety, and efficacy.