Metis Consulting Services
Pharmacovigilance Services, QA, Anaylsis, Process Development, Pre-Inspection Audit Readiness.

metis consulting services

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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