Sector
Pharmaceutical Sector
Comprehensive support for pharmaceutical companies that need to validate their manufacturing systems, ensure data integrity, and comply with the strict regulations of the FDA and EMA. With over 25 years of experience in the sector, we help our clients maintain compliance in a sustainable and efficient way.
Applicable regulations
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System Validation
Complete validation of computerized systems: ERP, LIMS, MES, mobile applications, medical devices and AI systems under GxP regulations and 21 CFR Part 11.
Data Integrity
Assessment and improvement of data integrity controls in accordance with ALCOA+, with remediation plans and training to ensure reliable and auditable data.
Auditing
Internal audits, technology vendor and third-party audits to identify compliance gaps and prepare your organization for regulatory inspections.
Training & Qualification
Specialized training programs in GxP, CSV, data integrity and regulatory requirements for quality, IT and operations teams.
Regulatory Consulting
Expert advice on the interpretation and application of GxP regulations: FDA, EMA, ICH, ISO 13485, MDR and other regulations applicable to your sector.