KRB Consulting



KRB CONSULTING

CASES SHOW

HOME

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

Case One

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.

CASES SHOW

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.

Oral Formulation Accept FDA PAI Inspection (“Zero deficiency”)

KRB GMP team provided consulting services for a company to prepare and pass FDA for an oral preparation. The consulting services included gap analysis, re-validation consulting, personnel training, system optimization and enhancement, translation and technical support during the inspection. The product had a unique process and during the inspection the auditor demonstrated a very impressive inspection skill. Finally this project passed the FDA pre-approval inspection without deficiency, which was also the client's first FDA inspection.

CONTACT

Phone number

Phone number：400-0123-669

Address

Address：A805, Tower A, Chaowai SOHO, 6B Chaowai Street, Chaoyang District, Beijing 100020

Wbsite

https://www.kingrabroad.com/

Email

E-mail：info@kingrabroad.com

KRB Consulting

Wechat account

Search for “KRB Consulting”

to know more!

Follow Us

language

বাংলাদেশ

Български

इंडिया

Հայաստան

ປະເທດລາວ

Малайская

Монгол улс

தமிழ்

नेपाल

Российская

ประเทศไทย

Copyright © 2023 KRB CONSULTING All Rights Reserved. 300.cn TAG Business License