KRB Consulting



KRB CONSULTING

CASES SHOW

HOME

Class 5.1 Imported Injection Got NMPA Approval

Case One

Class 5.1 Imported Injection Got NMPA Approval

KRB RA team supported for an overseas company to launch their injection with China NMPA which includes CTD dossier gap analysis, submission strategy development, project management, multiple rounds of guidance and review for the critical & major deficiencies recognized during gap analysis, professional document translation, NDA submission package preparation and submission, sample clearance and registration testing, CDE review following up, DL explanation and guidance for response, and DL response review following up until the final approval by China NMPA. This is an overseas marketed innovated product apply for NDA registration in China, we successfully helped the client to obtain local clinical trial exemption with overseas data so to enable NDA directly without local clinical trials, which was granted by NMPA and finally approved by NMPA.

CASES SHOW

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.

Non-terminally Sterilized Injectables Accept FDA PAI

KRB GMP team provided consulting services for a company to prepare and pass FDA inspection for a sterilized formulation. The consulting services included gap analysis, re-validation consulting, personnel training, system optimization and enhancement, technical support during inspection and response support. This product belongs to an FDA key focused drug product, during the audit process the FDA inspector's demonstrates a high level of inspection and strict rectification requirements. Finally this project passed the FDA pre-approval inspection with only one finding, which is also the first sterilized preparation of the client to pass FDA inspection. Meanwhile, this is the third international inspection cooperation between our client and our team.

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