Health Authority Inspections; Internal Audits
Do any of these scenarios fit your current situation?
Your organization is filing their first IND
Your organization is expanding MAH status to markets outside of the U.S. and emerging markets
There is an organizational need for an internal audit
You recognize the need to shore up interdepartmental alignment
Your organization is bridging to the next level of scalable development
Audit types include: Routine audits, Pre-Approval Inspection (PAI), Pre-Marketing Audit (PMA), Internal Audits, and Mock Audits. These audits are initiated by the FDA, Healthcare Products Regulatory Agency (MHRA), European Medicines Association (EMA), or any regulatory authority.
Metis Consulting has more than a decade of experience assisting companies in dealing with agencies and audit preparedness.
Call us at (760) 443-2659 to learn more, or send us an email at info@ metisconsultingservices.com
Last updated: 23 May 2019