At ERA Sciences, we bring extensive expertise across the life sciences, pharmaceutical, and medical devices sectors, providing a broad range of services designed to support regulatory compliance and operational excellence. Our team specializes in GMP, 21 CFR Part 11, Annex 11 and GAMP5 standards, ensuring that our clients meet industry-specific requirements for data integrity, quality risk management, and computer system validation.

We are particularly adept at addressing data integrity challenges through data integrity audits, data integrity assessments, and data flow mapping. Our experience in 21 CFR Part 11, Annex 11 and ALCOA Plus compliance has helped numerous clients achieve successful 483 remediation and long-term data governance strategies.

We have supported clinical trial management systems (CTMS) with platforms like Veeva, enabling seamless regulatory documentation and trial oversight. Our work with CDMOs ensures that third-party manufacturers meet GxP standards and comply with FDA, EUDRA and regulatory agency guidelines.