Regulatory Compliance
Stay ahead of regulatory demands with our Regulatory Compliance Auditing services
Regulatory Compliance
Galenisys conducts thorough audits to assess your adherence to global regulatory standards. Our detailed audits identify areas of non-compliance and provide actionable recommendations to address gaps. From initial assessment to follow-up support, we guide you through the complexities of regulatory landscapes, ensuring your operations meet and exceed FDA, EMA, and WHO requirements.
We can conduct complete compliance auditing along both FDA and EmA guidelines for GMPs, GLPs and GCPs, as well as other areas of your production and distribution chain, including:
- Active Pharmaceutical Ingredients (APIs)
- Manufacturing, packaging and distribution
- Suppliers of excipients, packaging components, services and equipment
- Analytical laboratories
- Clinical trials.
We can audit your quality systems to measure compliance with the specific requirements of:
- The US FDA
- ANSM (Agence Nationale de Sécurité du Médicament)
- The EMA and other European regulatory agencies
- Australian, Canadian and Japanese agencies.
