Aurum-Data is an expert on Quality Management Systems in the pharmaceutical industry. Through our unique approach to combining Quality Consultancy and Quality Management Systems, which are CFR part 21 compliant, we ensure GMP compliance and reduction in deviations, errors and ultimately cost. We comply with the quality standards set by the FDA and follow the best Data Management practices for Pharmaceutical Organization based on ALCOA principles.

Our pharmaceutical consultants offer practical knowledge and experience in implementing or enhancing your Pharmaceutical Quality Systems (PQS) to meet GMP code requirements and those based on ICH Q10/ISO 9001:2015 for Pharmaceuticals. GMP Audits – We assist our clients with GCP, GLP and GMP gap audits/assessments/remediation plans to help you prepare for regulatory audits and inspections from agencies such as TGA/MHRA/US FDA.