REGULATORY INSPECTION PREPARATION & RESPONSES

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Partner with client to develop roadmap for pre-approval inspection preparation and/or regulatory inspections prior, during and post inspections.
Partner with client to author or evaluate regulatory inspection responses.
Lead mock inspections (FDA, BIMO, Health Canada, EMA, MHRA, TGA and various BoH's authorities.

Dahlia Pharma Biotherapeutics Advisors Science

REGULATORY INSPECTION PREPARATION & RESPONSES

(Test Method and Stability Programs)

Partner with client to develop roadmap for pre-approval inspection preparation and/or regulatory inspections prior, during and post inspections.
Partner with client to author or evaluate regulatory inspection responses.
Lead mock inspections (FDA, BIMO, Health Canada, EMA, MHRA, TGA and various BoH's authorities.

Dahlia Pharma Biotherapeutics Advisors Science