We provide end-to-end pharmaceutical support services to strengthen compliance, ensure operational excellence, and prepare organizations for regulatory expectations. Our focus is on practical implementation, documentation accuracy, and continuous quality improvement.
Core Services
Documentation
Preparation and proposal of SOPs in line with global regulatory requirements, ensuring clarity, consistency, and compliance across operations.
Operational Excellence
Implementation of GMP practices and development of robust quality systems to drive efficiency, reduce errors, and improve compliance outcomes.
Digitalization of Calculations
Development and validation of Excel-based calculation tools tailored to client requirements, ensuring accuracy, traceability, and compliance with data integrity standards.
Pre-Audit Preparation
Comprehensive support for regulatory and client audits, including documentation review, staff readiness assessments, and compliance gap analysis.
Documentation Control
Ensuring adequacy of SOPs, integrity of batch records, and accuracy of validation protocols to maintain audit-ready documentation systems.
Data Integrity
Guidance on implementing ALCOA+ principles, establishing controls for electronic records, and ensuring trustworthy, reliable, and compliant data management.
Quality Management Systems (QMS)
Assessment and enhancement of QMS effectiveness with a focus on continuous improvement processes, CAPA management, risk assessment, and overall compliance culture.
Skill Development Trainings
Practical workshops and hands-on modules designed to upskill staff in technical, quality, and compliance functions, ensuring readiness for evolving industry demands.