Pharmaceutical Regulatory Agency Audits
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, Medicine Health & Regulatory Administration (MHRA), European Medicines Association (EMA), or any regulatory authority.
Do any of these scenarios fit your current situation?
You’re a smaller company seeking their first NDA
You’re expanding MAH status to growing markets (to Canada, the EU, South and Central America, India, China, and/or Africa)
It’s been a long time since your company’s last audit
Your team is lacking experience
Your end goals aren’t aligned across departments
You’re seeking a bridge to the next level of scalable development
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