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

Case Four

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.

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.

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.

505(b)(2) Lyophilized Microspheres Accept FDA PAI Inspection (“Zero deficiency”)

KRB GMP team provided consulting services for a company's lyophilized microspheres to prepare and pass for FDA pre-approval inspection. The consulting services included gap analysis, hardware renovation guidance, re-validation consulting, personnel training, system optimization and enhancement, and technical support during the inspection. This product has a very complex sterilized management including sterilized lyophilization, sterilized powder dispensing, non-terminal sterilization pre-filled syringe and other technologies. Finally this project pass FDA PAI without deficiency which is also the first Chinese 505(b)(2) sterilized preparation pass FDA inspection.

Lyophilized Formulation Accept EU Inspection

KRB GMP team provided consulting services for a Pharma Group to prepare and pass EU inspection for their lyophilized preparations. The consulting services included gap analysis, hardware renovation consulting, re-validation consulting, personnel training, system optimization and improvement, mock audit, translation and technical support during the inspection, as well as responses guidance. This inspection was carried out by EU inspectors in full compliance with EU GMP Appendix 1, which was also the first time for this client to pass an EU GMP inspection.

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