Auditing is an essential function for all pharmaceutical companies. It must be completed meticulously to ensure full compliance with relevant regulatory standards, which are monitored by regulatory agencies.

At Mobius, our specialist auditing team can help assess quality systems and conduct due diligence audits for both nished product manufacturers and contract laboratories.

Our solutions cater to the auditing requirements of both active pharmaceutical ingredients as well as excipients.

We provide expertise on the following audit services and solutions to help our clients meet regulatory requirements as well as support their entire manufacturing supply chain:

• Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)

We perform mock audits in line with EU and MHRA guidelines. Our mock audits also comply with ISO and WHO standards. These mock audits assess:

• Gaps in manufacturing and distribution operations
• CAPA implementations
• Audit Closure
• Other GMP compliance required for Marketing Authorisation (MA) application.