Company Performance Metrics
Regultech Solutions provides GxP compliance, computerized systems assurance, and quality assurance consulting for regulated life sciences organizations. The company focuses on supporting small biotechnology, pharmaceutical, and clinical research companies in meeting GxP requirements. Its services include advisory and validation support for FDA 21
CFR Part 11, EU GMP Annex 11, and related quality and data integrity standards. Regultech Solutions helps clients align computerized systems and digital records with regulatory expectations for electronic records and electronic signatures. It also supports audit readiness, documentation, and process optimization related to GxP and computer system validation. Engagements typically involve tailored consulting, procedural improvements, and training designed around each client’s systems and workflows. These offerings aim to integrate regulatory expectations into daily operations while maintaining consistent quality control and data integrity.
