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DD Service for an Investment Group to Acquire a Hit Drug Product

Case Two

DD Service for an Investment Group to Acquire a Hit Drug Product

KRB sent its GMP and RA experts to support for an investment Group for its regulatory DD before the acquisition of a hit drug product held by a Chinese Pharma which includes manufacturing site audit, product RA and market analysis, and risks assessment. Via this regulatory DD KRB team helped the acquirer to well understand the product advantages and risks, GMP compliance risks, process sustainability and personnel quality of the acquired company, and assisted in the decisions for the subsequent acquisition.

CASES SHOW

DD Service for a Foreign Enterprise to Acquire a Domestic Chinese Pharma

KRB sent its GMP and RA experts to support for a France Enterprise for its regulatory due diligence (DD) before the acquisition of a local Chinese Pharma which includes onsite audit, risks assessment and guidance for remediations. Via this regulatory DD KRB team helped the acquirer to well understand the product advantages and risks, GMP compliance risks, process sustainability and personnel quality of the acquired company, and assisted in the decisions for the subsequent acquisition.

DD Service for a Global Investment Group to Invest a Local Chinese Pharma

KRB sent its GMP experts to join in a Global Investment Group team to perform DD to its candidate Pharma who received a warning letter earlier by an overseas Health Authorities due to the product defects, and KRB experts were designated to investigate for the Pharma’s CAPAs taken and risks left over from last inspection, proposal on risks analysis and investment were also given by KRB experts. This consulting service helped the investor to have a more in-depth understanding in the progress of remediations taken by the investee and the remaining risks.

DD Service for a Foreign Group to Acquire a Domestic Chinese Pharma

KRB sent its GMP and RA experts to support for a Switzerland Group for its regulatory due diligence (DD) before the acquisition of a local Chinese Pharma which includes onsite audit, risks assessment and guidance for remediations. Via this regulatory DD KRB team helped the acquirer to well understand the product advantages and risks, GMP compliance risks, process sustainability and personnel quality of the acquired company, and assisted in the decisions for the subsequent acquisition.

Lyophilized Formulation Accept PIC/S&TGA Inspection

KRB GMP team provided consulting services for a Pharma Group to prepare and pass Australian TGA inspection for their lyophilized formulations. The consulting services included gap analysis, hardware renovation guidance, re-validation consulting, personnel training, system upgrading and enhancement, translation and technical support during the inspection, and Response strategies and guidance. This TGA inspection was conducted in full accordance with EU GMP Appendix 1, demonstrating a very rigorous, high standard and regulatory required audit procedure, and finally this customer passed the TGA inspection.

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