Qdot Associates Services And Solutions

Remediation for regulatory actions

We support partners in responding to inspectional observations and enforcement actions by developing strategic plans. We help partners in providing the comprehensive and holistic responses applicable in relation to FDA 483s, Critical observations from Europe regulations and warning letters. we evaluate the observations for implementation of ‘Systemic” corrections.We propose containment actions, Immediate and intermediate controls.

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Testimonials

Emilia Clarke
Moonkle LTD,
Client of Company
"Very well thought out and articulate communication. Clear milestones, deadlines and fast work. Patience. Infinite patience. No shortcuts. Even if the client is being careless. The best part...always solving problems with great original ideas!."
Emilia Clarke
SoftTech,
Manager of Company
"Patience. Infinite patience. No shortcuts. Very well thought out and articulate communication. Clear milestones, deadlines and fast work. Even if the client is being careless. The best part...always solving problems with great original ideas!."
Emilia Clarke
Moonkle LTD,
Client of Company
"Very well thought out and articulate communication. Clear milestones, deadlines and fast work. Patience. Infinite patience. No shortcuts. Even if the client is being careless. The best part...always solving problems with great original ideas!."
Emilia Clarke
SoftTech,
Manager of Company
"Patience. Infinite patience. No shortcuts. Very well thought out and articulate communication. Clear milestones, deadlines and fast work. Even if the client is being careless. The best part...always solving problems with great original ideas!."