Any organization associated with regulated activities requires routine inspection and GxP audits.

These activities include:

Pre-approval inspections are a large part of inspections and your license to operate and commercially manufacture products.

METIS Helps You Stay Compliant

Such companies are expected to be compliant and continuously improve. We can help you maintain alignment with new, existing, and changing regulations and industry standards that evolve throughout the drug product and device lifecycle.

The team will work directly with you to prepare for pre-BLA meetings, compile clinical trial study integrated safety and efficacy summaries, and conduct GMP pre-approval mock inspections. Throughout the process, we help you refine your regulatory strategy in line with your selected pathway.

Audits and Inspections are a Cornerstone

Audits and Inspections are a cornerstone of the compliance of an organization. Internal audits show us where we have work to do, and vendor audits ensure that vendors are compliant with regulatory requirements and their contractual obligations.

Preparedness for Health Authority Inspection is critical for the success of a department or an organization. The Metis team are seasoned professionals with decades-deep experience in the pharmaceutical and biotechnology industries. The hands-on guidance they provide is always geared towards helping you move smoothly into the next phase – so you can rapidly and ethically get your product to market and to patients safely.

Metis provides expertise across the Regulatory Spectrum by auditors who are proficient in conducting:

• Annual routine audits
• Gap Assessments
• Pre-Approval Inspection (PAI)
• Pre-Marketing Audit (PMA)
• Internal Audits
• Vendor and Supplier Audits
• Mock Inspections

We serve as an extension of an organization’s Quality Department with respect to vendor and supplier auditing.  Or act as a mock regulatory agency representative with respect to preparing your organization for an agency inspection. Partnering in a collaborative and constructive manner, we work together to understand, identify, and evaluate systems for quality improvements.

Our large network of compliance consultants covers the globe and has broad knowledge across the regulatory spectrum (GMP, GCP, GLP, GPV, GDPR, Med. Dev., CSV, DI, etc.).

These inspections are initiated by FDA, EMA (European Medicines Agency), MHRA (Medicines and Healthcare products Regulatory Agency), or any health authority.