Regulatory compliance auditing

If you want to make certain your facilities and procedures are compliant with regulations, ask Galenisys to perform a compliance audit. Also Galenisys can provide a full audit of your CMC current practices against the product registrations or licenses.

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.

A complete quality systems audit and follow-up

If you need to make sure your quality systems comply with the regulations set out by a specific agency, Galenisys can provide a complete audit of your quality systems – giving you peace of mind and helping you identify and make changes where you need to.

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.

We can also broaden the scope of our audit to include all areas of your company’s or facility’s activities, including:

• Due diligence
• Product and process development
• Capital investment projects.

When the audit is complete, we will provide you with a formal report as well as follow-up consultations to monitor and implement corrective actions and improvements to your processes, as revealed by the audit.